[The efficacy of paracetamol (Tylenol) and acetyl salicylic acid (Aspirin) in treating postoperative pain]. A double-blind comparative evaluation of aspirin, paracetamol and paracetamol + caffeine (finimal) for their analgesic effectiveness. Oral analgesic efficacy of suprofen compared to aspirin, aspirin plus codeine, and placebo in patients with postoperative dental pain. A controlled comparative evaluation of acetaminophen and aspirin in the treatment of postoperative pain. Caffeine as an analgesic adjuvant. A double-blind study comparing aspirin with caffeine to aspirin and placebo in patients with sore throat. Analgesic effect of aspirin, mefenamic acid and their combination in post-operative oral surgery pain. Aspirin in the treatment of episiotomy pain. A double-blind randomized study of an aspirin/caffeine combination versus acetaminophen/aspirin combination versus acetaminophen versus placebo in patients with moderate to severe post-partum pain. Double-blind comparison of an acetaminophen 400 mg-codeine 25 mg combination versus aspirin 1000 mg and placebo in acute migraine attack. Comparative analgesic potency of aspirin and ibuprofen. Replicate studies comparing the relative efficacies of aspirin and indoprofen in oral surgery outpatients. The relative analgesic efficacy of propiram fumarate, codeine, aspirin, and placebo in post-impaction dental pain. An investigation into the comparative efficacy of soluble aspirin and solid paracetamol in postoperative pain after third molar surgery. A double-blind placebo-controlled comparison of three ibuprofen/codeine combinations and aspirin. Analgesic efficacy of an orally administered combination of pentazocine and aspirin. With observations on the use and statistical efficiency of GLOBAL subjective efficacy ratings. Comparison of flurbiprofen and aspirin in the relief of postsurgical pain using the dental pain model. The analgesic efficacy of suprofen in periodontal and oral surgical pain. Assay of aspirin and naproxen analgesia. Aspirin is efficacious for the treatment of acute migraine. Analgesic effect of fendosal, ibuprofen and aspirin in postoperative oral surgery pain. Efficacy of low dose combination analgesics: acetaminophen/codeine, aspirin/butalbital/caffeine/codeine, and placebo in oral surgery pain. Comparative efficacy of soluble aspirin and aspirin tablets in postoperative dental pain. Double-blind evaluation of suprofen and aspirin in the treatment of periodontal pain. Analgesic effect of graded doses of flurbiprofen in post-episiotomy pain. Aspirin and aspirin-caffeine in postpartum pain relief. Ibuprofen, zomepirac, aspirin, and placebo in the relief of postepisiotomy pain. A single-dose study of the efficacy and safety of FS 205-397 (250 mg or 500 mg) versus aspirin and placebo in the treatment of postsurgery dental pain. A comparison of four analgesics in post-episiotomy pain. The effectiveness of 100 and 200 mg etodolac (Ultradol), aspirin, and placebo in patients with pain following oral surgery. Analgesic efficacy of bromfenac, ibuprofen, and aspirin in postoperative oral surgery pain. Analgesic effect of an aspirin-codeine-butalbital-caffeine combination and an acetaminophen-codeine combination in postoperative oral surgery pain. Analgesic efficacy of an ibuprofen-codeine combination. A double-blind parallel evaluation of the efficacy and safety of a single dose of ketoprofen in cancer pain. Aspirin compared with acetaminophen in the treatment of fever and other symptoms of upper respiratory tract infection in adults: a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single-dose, 6-hour dose-ranging study. An evaluation of flurbiprofen, aspirin, and placebo in postoperative oral surgery pain. Additive analgesic effect of codeine and paracetamol can be detected in strong, but not moderate, pain after Caesarean section. Baseline pain-intensity is a determinant of assay-sensitivity in a postoperative analgesic trial. Evaluation of ketorolac, aspirin, and an acetaminophen-codeine combination in postoperative oral surgery pain. An evaluation of different doses of soluble aspirin and aspirin tablets in postoperative dental pain. An evaluation of the analgesic efficacy of proquazone and aspirin in postoperative dental pain. Evaluation of aspirin, caffeine, and their combination in postoperative oral surgery pain. Analgesic efficacy of acetaminophen 1000 mg, acetaminophen 2000 mg, and the combination of acetaminophen 1000 mg and codeine phosphate 60 mg versus placebo in acute postoperative pain. Fendosal and aspirin in postpartum uterine pain. Analgesic efficacy of amfenac, aspirin and placebo after extraction of impacted teeth. Comparison of the analgesic efficacy of flurbiprofen and aspirin for postsurgical dental pain. Mouth-dispersible aspirin in the treatment of migraine: a placebo-controlled study. A multicentre placebo-controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low-back pain. Naproxen, aspirin, and codeine in postpartum uterine pain. Flurbiprofen, aspirin, codeine, and placebo for postpartum uterine pain. Comparative effectiveness of five analgesics for the pain of rheumatoid synovitis. The efficacy of etodolac for patients with pain following oral surgery. A 12-hour evaluation of the analgesic efficacy of diflunisal, aspirin, and placebo in postoperative dental pain. Fluradoline and aspirin for orthopedic postoperative pain. Double-blind comparison of single oral doses of oxaprozin, aspirin, and placebo for relief of post-operative oral surgery pain. Ibuprofen and acetaminophen in the relief of acute pain: a randomized, double-blind, placebo-controlled study.
In a randomized, double-center, double-blind, parallel group study the analgesic effect of a single dose of paracetamol (1000 mg) and acetyl salicylic acid (1000 mg) was compared with placebo in patients with moderate to severe postoperative pain following the surgical removal of a wisdom tooth. The most important finding was the statistically significantly shorter period until the onset of the action of paracetamol as against acetyl salicylic acid. A double-blind, cross-over trial was made of three analgesic preparations--paracetamol, paracetamol with caffeine (Finimal) and aspirin in the relief of postoperative pain in 72 orthopedic inpatients and in 144 ambulatory outpatients suffering form common idiopathic headache. The combination of paracetamol and caffeine (Finimal) in this study shows the greatest pain relief in both groups of patients. This evaluation supports the results of BOOY3 demonstrating the superiority of the paracetamol-caffeine combination to paracetamol alone or aspirin. The purpose of this study was to evaluate the analgesic efficacy and safety of single oral doses of suprofen 200 and 400 mg, compared with aspirin 650 plus codeine 60 mg, aspirin 650 mg, and placebo in the relief of moderate to severe pain resulting from the surgical removal of impacted third molars. 157 patients completed a randomized, double-blind, single-dose, stratified, parallel-groups trial, and were observed for at least 4 h. Based upon each of the summary efficacy measures, sum pain intensity difference (SPID), percent SPID, TOTPAR and a global evaluation, all four active treatments were approximately equally effective and all were statistically superior to placebo. In addition, suprofen at both dose levels was significantly more effective than placebo beginning at the 0.5-hour observation for mean pain intensity, whereas the two aspirin treatments were not superior to placebo until the 1-hour observation. Side effects were minimal; there was one in the suprofen 200 mg, three in the aspirin 650 mg, and one in the placebo treatment group. Thus, it appears that suprofen at 200 and 400 mg is a safe and effective oral analgesic for the relief of moderate or severe postoperative dental pain, and it is possible that compared to aspirin 650 mg and aspirin 650 mg plus codeine 60 mg, it has a more rapid onset of action. The analgesic effects of acetaminophen (1 gm), aspirin (650 mg), and placebo were evaluated in a double-blind, randomized parallel study. The subjects were 162 outpatients who had experienced moderate or severe pain as a result of dental surgery involving bone removal. Patients evaluated the intensity of their pain and the extent of their relief from pain at 30 minutes, at one hour, and at each subsequent hour for six hours after the administration of the study medication. During the six-hour period, 135 of the 162 patients were remedicated. At the end of the six-hour period each patient assessed overall treatment. Two measures of analgesia were derived from patients' evaluations of the intensity of pain, and three other measures were derived from evaluations of relief from pain. On all six measures used, the groups receiving acetaminophen and aspirin reported analgesic effects significantly superior (P less than 0.05) to those of placebo. Acetaminophen was significantly better than aspirin with respect to the maximum difference in the intensity of pain (P less than 0.05) and the maximum pain relief achieved (P less than 0.03) and according to the global evaluation (P less than 0.02). These differences were most striking in patients with severe initial pain. Despite its frequent clinical use in analgesic agents, caffeine has not been accepted unequivocally as an analgesic adjuvant. To evaluate this activity of caffeine, we used new study methods in a randomized controlled trial on patients with acute sore throat due to tonsillopharyngitis. Patients were randomly assigned to receive a single dose of one of three treatments: 800 mg of aspirin with 64 mg of caffeine (n = 70), 800 mg of aspirin (n = 68), or placebo (n = 69). Under double-blind conditions, during a 2-hour evaluation period, patients used different rating scales to assess pain intensity, change in pain, relief, and two qualities of throat pain, how swollen the throat felt, and difficulty swallowing. Aspirin with caffeine and aspirin alone were significantly more effective than placebo for all efficacy measurements from 30 minutes through 2 hours and overall. The aspirin-caffeine combination also showed evidence of activity at 15 minutes on the relief scale. Aspirin with caffeine was more effective than aspirin alone after 30 minutes and over the entire study period. For patients with fever, both active treatments were equally effective antipyretic agents. We conclude, therefore, that 800 mg of aspirin, given alone or with 64 mg of caffeine, is an effective analgesic and antipyretic agent. Because the aspirin-caffeine combination is significantly more effective than aspirin alone as an analgesic, we also conclude that 64 mg of caffeine is an analgesic adjuvant. A double-blind randomized single dose study of the analgesic effects of 650 mg aspirin, 250 mg mefenamic acid, the combination of 650 mg aspirin and 250 mg mefenamic acid and placebo on 120 patients with pain following oral surgery was conducted. Patients evaluated their pain intensity and extent of pain relief at 1, 2, 3 and 4 h after drug administration. For most parameters, including the sum of the pain intensity differences and the sum of the hourly pain relief scores, each of the drugs was more effective than placebo. Aspirin-mefenamic acid in combination was more effective than both drugs alone, and aspirin and mefenamic acid alone were equally effective for most of the analgesic variables. We studied 160 postpartum women having moderate to severe episiotomy pain to determine the efficacy of aspirin analgesia, with 5, 10, and 20 grain doses, as compared to placebo. Over a four-hour period, all groups treated with aspirin showed significantly more improvement in pain intensity scores than those given placebo. Only a small percentage of patients required additional analgesic medication. This study shows that aspirin alone is an effective treatment for relief of moderate to severe episiotomy pain. In a double-blind, randomized controlled trial among 500 post-partum patients experiencing moderate to severe pain, a single oral dose of an aspirin/caffeine combination (800 mg aspirin, 65 mg caffeine) provided significantly more pain relief at 2 hours than did a higher dose of an acetaminophen/aspirin combination (648 mg acetaminophen, 648 mg aspirin) and a higher dose of acetaminophen alone (1000 mg acetaminophen). At 3 and 4 hours, the acetaminophen/aspirin combination as well as the aspirin/caffeine combination were significantly superior to acetaminophen alone. At all times, all three drugs were significantly superior to placebo. There were no clinically significant adverse reactions. These results provide evidence of a potentiating effect of caffeine on aspirin's analgesic potency. The purpose of this study was to compare the efficacy and tolerance of a single dose of the acetaminophen 400 mg-codeine 25 mg combination (ACC) aspirin 1000 mg (A) and a placebo (P) for the treatment of acute migraine attack. The study design was randomized, multicentre, double-blind and double dummy with cross-over on three periods. Of the 198 patients who had three attacks 29.8%, 52.3% and 49.7% had recorded the complete or almost complete disappearance of the pain at 2 h after P, A and ACC respectively. When compared with the placebo, the difference was significant for the A and ACC. When complete disappearance of pain at 2 h was used as a criterion, no significant difference was observed. These results enabled the sensitivity of the evaluation criteria suggested for clinical trials of migraine attack to be discussed. The object of a study was to evaluate the analgesic efficacy of ibuprofen for dental pain. The subjects were outpatients who were undergoing surgical removal of impacted teeth. We compared aspirin, 325 mg; aspirin, 650 mg; ibuprofen, 200 mg; ibuprofen, 400 mg; and placebo. Each patient received a single dose of one of the test medications; there was a minimum of 37 patients in each treatment group. Patients recorded pain intensity before receiving medication; then hourly, for four hours after medication, they recorded pain intensity, amount of relief, and side effects. Time-effect and dose-response curves were generated from the relief and change in pain-intensity scores. First-hour scores, peak scores, and total scores were analyzed. All active medications were significantly better than placebo and the mean effect for ibuprofen was significantly more than for aspirin. The results from the present studies confirm that indoprofen is an orally effective analgesic drug. Both the 100- and 200-mg dosages of indoprofen demonstrated superior analgesic activity when compared to 600 mg aspirin. To evaluate the analgesic efficacy of orally administered 50 mg propiram fumarate, 650 mg aspirin, 60 mg codeine phosphate, and placebo in acute post-impaction dental pain, 159 patients with moderate or severe pain were randomly allocated to the four treatments in this single-dose double-blind, stratified, parallel-group study. A research nurse questioned the patients at 1/2 hour and hourly for 6 hours after medicating. A standard format was used to question subjects about their pain intensity and relief from the starting pain. Propiram, 50 mg, produced a level of analgesia approaching that of 650 mg aspirin in peak effect, total effect, and duration of action and was statistically superior to 60 mg codeine and placebo for every measure of analgesic efficacy. Several mild adverse effects were observed; however, they appeared to be evenly distributed among the active treatments. To compare the efficacy of soluble aspirin 900 mg and paracetamol 1,000 mg in patients with postoperative pain after third molar surgery.
                A randomised, placebo controlled, double-blind study.
                Day stay units of Oral and Maxillofacial Surgery at Cardiff Dental Hospital and Hexham General Hospital, Northumberland.
                One hundred and sixty-seven (104 female) patients who required the removal of their impacted third molars under general anaesthesia.
                In the early postoperative period, patients were medicated with either a single dose of soluble aspirin 900 mg, solid paracetamol 1,000 mg or placebo.
                Pain intensity was measured on 100 mm visual analogue scales at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120 and 240 minutes after dosing. Other efficacy variables evaluated included time to rescue medication and an overall assessment of the study medication efficacy by the patient on completion of the study.
                One hundred and sixty-seven patients consented to take part in the study, but only 153 were medicated. Of the 14 patients not treated, 10 failed to develop sufficient pain to enter the study, two withdrew consent, one had an adverse reaction to the general anaesthetic and one was a protocol violator. Over the four hour investigation period, patients treated with soluble aspirin reported significantly less pain when compared with those treated with paracetamol (mean difference in AUC(0-240) = -2001, 95% CI -3893 to -109, p=0.038) and placebo (mean difference in AUC(0-240) = -3470, 95% CI -5719 to -1221, p=0.003). Similarly, at 20 and 30 minutes after dosing, patients in the soluble aspirin group were reporting significantly less pain than those in the paracetamol treatment group (mean difference in pain intensity: at 20 minutes -7.9, 95% CI -15.3 to -0.6, p=0.035; at 30 minutes -10.6, 95% CI -18.6 to -2.6, p=0.010). There were no significant differences between treatment groups with respect to the number of patients requiring rescue medication, however the time to dosing was significantly longer for those taking soluble aspirin when compared with placebo (hazard ratio 2.34, 95% CI 1.41 to 3.88, p<0.001).
                The findings from this study showed that soluble aspirin 900 mg provides significant and more rapid analgesia than paracetamol 1,000 mg in the early postoperative period after third molar surgery. In a double-blind, single dose study of analgesic efficacy, 165 patients who were expected to develop moderate to severe pain following the removal of an impacted mandibular third molar tooth were allocated to receive aspirin, placebo, or an increasing dose of a fixed ratio ibuprofen/codeine combination. The degree of pain experienced prior to medication was noted and the patients were asked to record the degree of pain and of pain relief hourly for the following 5 hours. The study produced clear evidence of the superior efficacy of the combinations when compared to placebo and aspirin. In addition, the high dose combination appeared to be superior with respect to pain relief and the need for additional analgesia compared to the low dose treatment. There were few side effects and only one severe reaction was reported by a patient in the high dose group. To avoid side effects it is suggested that the medium-dose combination, ibuprofen 400 mg/codeine 30 mg, is optimal. The analgesic efficacy of a combination of pentazocine and aspirin (PA) in the ration 1:13 was compared with that of 650 mg of aspirin alone (A650) and with placebo (PBO), in 98 patients with postoperative pain. Two dose levels of the combination were compared: the lower dose (PA-L) consisted of pentazocine 25 mg and aspirin 325 mg, while the higher dose (PA-H) consisted of pentazocine 50 mg and aspirin 650 mg. All active treatments performed significantly better than PBO. PA-L performed as well as A650, while PA-H performed significantly better than A650. In addition to the usual subjective measures of analgesia, we obtained in 74 patients an evaluation of the overall (GLOBAL) performance of the treatment. This was rated on an ordinal scale of 1 ("poor") to 5 ("excellent"). On the GLOBAL scale, PBO had a mean score of 2.4 (fair-good); A650 and PA-L had scores of 3.6 and 3.9 respectively (good-very good): and PA-H had a score of 4.5 (very good-excellent). In five of six comparisons between treatment means, GLOBAL had the best discriminating power of all six measures. In the two comparisons of greatest interest (A650 against PBO and PA-H against A650), GLOBAL was more than twice as efficient as the TOTAL (summed pain score) measure. In comparing the statistical efficiency of different measures of the same analgesic effect, there is a problem in determining what are "clinically equivalent differences" on the various analgesic scales employed. We propose the use of the observed sample differences and the safeguard of repeating the comparisons over several studies to minimize the effect of random-origin bias. This single-dose, double-blind, randomized, placebo-controlled study evaluated the analgesic efficacy of both 25 and 50 mg of flurbiprofen (Ansaid, Upjohn) compared with 650 mg of aspirin and placebo in 164 patients who had undergone dental impaction surgery. Using the highly sensitive dental pain model, flurbiprofen appears to be an effective, peripherally acting analgesic with a rapid onset of activity. In the current study, it was superior to aspirin in terms of peak effect and duration of action. Although flurbiprofen is much more potent than ibuprofen, its side-effect profile did not differ markedly from that of ibuprofen in this single-dose study. Suprofen is a new, orally effective nonsteroidal antiinflammatory analgesic of the propionic acid chemical class. Three separate single-dose studies were performed to evaluate the efficacy of suprofen in acute pain associated with periodontal surgery and removal of impacted third molars. Study medications were: A--suprofen 200 mg, codeine 60 mg, propoxyphene HCl 65 mg, and placebo; B--suprofen 400 mg and 200 mg, aspirin 650 mg, and placebo; C--suprofen 400 mg and 200 mg, aspirin 650 mg with codeine 60 mg, aspirin 650 mg alone, and placebo. Analgesic and side effect data were collected over a 6-hour period after patients medicated for moderate to severe pain. All studies were randomized, double-blinded, and parallel-group in design. Suprofen was significantly more effective than codeine 60 mg, propoxyphene HCl 65 mg, and aspirin 650 mg. Suprofen 400 mg appeared to be clinically more effective than the aspirin-codeine combination and the difference was statistically significant for most of the analgesic variables. Of the 224 patients who received suprofen in the 3 studies, 16 reported drowsiness and 1 reported constipation. To establish the relative potency of naproxen and aspirin for oral analgesia, a 4-point, noncrossover bioassay with placebo control was undertaken with 197 patients. Subjective-response methods were used to determine two measures of postoperative analgesia over a period of 6 hr. With reasonable confidence for an oral analgesic assay, we found 220 mg of naproxen to be equivalent to 600 mg of aspirin for pain relief and 330 mg of naproxen to be equivalent to 600 mg of aspirin for decreased pain intensity. More than 50% of migraine sufferers rely on over-the-counter medications for the treatment of migraine. Along with other over-the-counter products, aspirin is considered by the US Headache Consortium to be an option for first-line migraine treatment. This study assessed the efficacy and tolerability of aspirin versus placebo for the acute treatment of a single acute attack of migraine.
                This prospective, randomized, double-blind, parallel-group, placebo-controlled study evaluated the efficacy of a single, 1000-mg dose of aspirin for the treatment of acute moderate to severe migraine, with or without aura. Subjects recorded all study evaluations in a diary at baseline and at .5, 1, 2, 3, 4, 5, 6, and 24 hours after treatment. Pain was rated on a 4-point ordinal scale from no pain to severe pain. The primary efficacy end point was headache response at 2 hours. Secondary efficacy parameters included reduction of nausea, photophobia and phonophobia, pain intensity difference, and headache recurrence at 24 hours.
                Of 485 subjects enrolled, 409 took study medication and 401 treated a confirmed migraine attack (201 with aspirin and 200 with placebo). Baseline demographic and migraine characteristics were not significantly different between groups. The 2-hour headache response rate was 52% with aspirin versus 34% with placebo (P<.001). Aspirin was significantly more effective than placebo for pain reduction beginning 1 hour after dosing (P<.001) and continuing throughout the 6-hour evaluation period. Significantly (P<.05), more subjects were pain free from the 1-hour evaluation through the 6-hour evaluation. Of the aspirin-treated subjects, 20% were pain free at 2 hours versus only 6% of placebo-treated subjects. At 24 hours, the headache recurrence rate was 21.8% for aspirin (23 of 105 subjects) and 27.7% for placebo (19 of 68 subjects). Only 34% of aspirin-treated subjects needed rescue medication at 24 hours compared with 52% of placebo-treated subjects (P<.001). Aspirin was well tolerated, and adverse events were not significantly different between groups.
                This study demonstrates that aspirin is safe and effective for treatment of acute migraine in appropriately selected patients. The analgesic efficacy of a single 200-mg dose of fendosal, a nonnarcotic, nonsteroidal antiinflammatory analgesic, was compared, in a double-blind study, with aspirin 650 mg, ibuprofen 400 mg and placebo in outpatients who had moderate or severe pain after the surgical removal of impacted third molars. Using a self-rating record, patients rated their pain and its relief hourly for up to 12 hours after medicating. Each active medication was significantly superior to placebo. The peak analgesic effect of fendosal 200 mg was similar to that of the aspirin 650-mg standard. Although fendosal's onset of action was slow (3 hours), its effect persisted for 8 hours, substantially longer than that of aspirin. Ibuprofen 400 mg was statistically significantly superior to aspirin 650 mg and fendosal 200 mg for most measures of peak and total analgesia, and its effect persisted for 8 hours. The results of this study raise some questions concerning the comparability of data from studies that employ different criteria for remedication and/or different criteria for the inclusion of data in the analyses of efficacy. A double-blind, randomized, single-dose study was performed to compare the efficacy and safety of two commonly prescribed combination analgesic products to placebo. The combinations were acetaminophen 300 mg/codeine 30 mg(†), and aspirin 325 mg/butalbital 50 mg/caffeine 40 mg/codeine 30 mg(††). One hundred twenty-three (123) oral surgery outpatients took study medications when their pain became moderate to severe and recorded the levels of pain intensity, pain relief, anxiety and relaxation at 30 minutes and hourly for 6 hours after dosing. Remedication was permitted if study medications did not provide adequate pain relief. Time to remedication, and the number of observations with 50% or better relief, were noted as were any side effects. An overall evaluation was obtained from each patient. Results of the study showed that the aspirin/butalbital/caffeine/codeine combination was significantly more effective than placebo for total pain relief, peak relief and global evaluation. While the acetaminophen/codeine combination was numerically superior to placebo, it achieved statistical significance only for global evaluation. The aspirin/butalbital/caffeine/codeine combination was numerically superior to acetaminophen/codeine for every measure of analgesic efficacy but the differences did not achieve statistical significance. Both active treatment groups experienced significantly less total anxiety than did the placebo group. Only 11 patients reported mild, transient adverse effects; the most common was drowsiness. The adverse effects occurred equally among the three treatment groups. In this study, the aspirin/butalbital/caffeine/codeine combination was significantly superior to placebo and somewhat better than acetaminophen/codeine. The efficacy of single doses (1.2 g) of soluble aspirin and aspirin tablets was determined in a randomised, placebo-controlled, double-blind, parallel study in 90 patients (45 females) with postoperative pain after removal of impacted lower third molars. Also investigated was the relationship between plasma aspirin esterase activity and overall pain scores after both aspirin preparations. Patients reported significantly less pain (p less than 0.001) after treatment with aspirin than after treatment with placebo. However, patients receiving soluble aspirin reported both an earlier onset and a longer duration of pain relief than those who received aspirin tablets. A significant correlation was observed between plasma aspirin esterase activity and overall pain scores after both soluble aspirin (r = 0.57, p less than 0.01) and aspirin tablets (r = 0.51, p less than 0.02). It is concluded that soluble aspirin is the preferred aspirin formulation for treating postoperative pain after third molar surgery and that plasma aspirin esterase activity is determinant of a patient's analgesic response to aspirin in postoperative dental pain. A double-blind, randomized, parallel group, placebo-controlled study was carried out to compare the safety and efficacy of single doses of suprofen (200 mg and 400 mg) with aspirin (650 mg) and placebo in relieving pain. In patients with pain resulting from periodontal surgery, a single dose of suprofen 200 or 400 mg was significantly better than placebo in reducing pain intensity and providing pain relief. The superiority of both doses of suprofen over placebo was demonstrated in every parameter in which pain intensity or pain relief was calculated. In addition, both doses of suprofen were better than, or at least equivalent to, aspirin 650 mg in every efficacy measure including the patients' overall acceptability of treatment. Our purpose was to evaluate the analgesic efficacy and safety of single oral doses of flurbiprofen 25, 50 and 100 mg, aspirin 600 mg, and placebo in the relief of moderate to severe post-episiotomy pain. One hundred and fifty-two evaluable patients completed a randomized, double-blind, stratified, parallel groups study. They were observed over a six hour period by one nurse-observer. Based upon each of the summary efficacy measures SPID, TOTAL and PEAK % and most of the hourly direct measures of pain intensity and pain relief, each of the four active treatments were statistically superior to placebo. Flurbiprofen 25 mg appeared to be slightly less effective than aspirin 600 mg, but the differences were not statistically significant. Flurbiprofen 50 and 100 mg were quite similar and were significantly more effective than aspirin 600 mg and flurbiprofen 25 mg. There were no observed or reported adverse effects. In two double-blind randomized, balanced, single oral dose studies with 140 women, a combination of 800 mg aspirin and 64 mg caffeine (aspirin-caffeine) was compared to 650 mg aspirin and to placebo. In patients with moderate to severe uterine or episiotomy pain, there was greater analgesic response with active drugs when the initial pain intensity was more severe. In patients with severe episiotomy pain, aspirin-caffeine was more effective than 650 mg aspirin (p less than 0.05) at the second and third hours. There was no difference between analgesic effects of aspirin and aspirin-caffeine in women with severe uterine pain. Our purpose was to compare the analgesic efficacy of single oral doses of ibuprofen, zomepirac, aspirin, and placebo in severe postepisiotomy pain. One hundred twenty subjects participated in a double-blind, single-dose, parallel-group, 4-hr trial comparing 400 mg ibuprofen, 100 mg zomepirac sodium, 600 mg aspirin, and placebo. For most parameters, including the sum of the pain intensity differences (SPID) and the sum of the hourly pain relief values (TOTAL), which are summary variables, each of the drugs was more effective than placebo. Ibuprofen was more effective than aspirin and zomepirac. Zomepirac and aspirin were equally effective for most of the analgesic variables. There were no adverse effects. Ibuprofen, 400 mg, is an effective oral analgesic and is more effective than 100 mg zomepirac and 600 mg aspirin in most parameters of pain. The efficacy and safety of two dose levels of FS 205-397 (either 250 or 500 mg) were compared with the efficacy and safety of aspirin 650 mg and placebo in a 6-hour, single-dose, double-blind study in 161 patients who had undergone extraction of third molars. Each of the doses of FS 205-397, as well as aspirin, produced analgesia. However, the analgesic effects of both the 500 mg dose of FS 205-397 and aspirin were at times significantly better and more prolonged than those produced by the lower dose of FS 205-397. On the other hand, both doses of FS 205-397 had a significantly faster onset of action than aspirin. Side effects, reported by 17% of the 161 patients, did not differ significantly among the four treatment groups with respect to frequency, type, or severity. The most commonly reported side effects were nausea (7%) and drowsiness (6%). The results indicated that FS 205-397, administered in single doses of either 500 or 250 mg, is a safe and effective analgesic for the relief of pain following dental surgery, and may offer particular advantages in terms of onset of effects. This study was conducted to compare the analgesic efficacy of four commonly used analgesics namely ibuprofen, analgin, paracetamol and aspirin in post-episiotomy pain. The subjects were healthy postpartum women on the obstetric service of Goa Medical College, each of whom received only one experimental medication. Subjective reports were used as indices of pain intensity or relief. Ibuprofen was found to be the most effective analgesic in post-episiotomy pain followed by analgin and paracetamol in that order. Surprisingly, aspirin was found to be no better than placebo. The analgesic efficacy of etodolac (Ultradol) was evaluated in 168 patients experiencing moderate to severe pain following oral surgery. The patients were given either etodolac 100 mg, etodolac 200 mg, aspirin 650 mg, or placebo. There was a minimum of forty patients in each drug group. Patients recorded pain intensity and pain relief at 1/2 hour and then hourly for up to 12 hours after medication. The efficacy variables analyzed were the sum of pain-intensity differences, total pain relief, onset of analgesia, and the patient's opinion of the study drug. Time-effect curves were made from the pain-relief and pain-intensity difference scores. The analgesic potency of both 100 and 200 mg of etodolac was comparable to 650 mg of aspirin and superior to placebo. Like aspirin, both doses of etodolac showed significant analgesia within one hour and a significantly longer duration of action than placebo. We recently demonstrated that 25 mg of bromfenac, a new nonsteroidal anti-inflammatory analgesic, is at least as effective as 400 mg of ibuprofen in relieving postoperative oral surgery pain. Our objective in this study was to determine whether higher doses were significantly more effective. Two hundred eighty (280) outpatients with postoperative pain after the surgical removal of impacted third molars were randomly assigned, on a double-blind basis, a single oral dose of 10, 25, 50, or 100 mg bromfenac; 650 mg aspirin; 400 mg ibuprofen; or placebo. Subjects rated their pain and its relief for 8 hours. All active treatments were significantly superior to placebo, and bromfenac and ibuprofen were significantly superior to aspirin. The slope of the dose-response curve of bromfenac was significant. The 100 mg bromfenac dose was significantly more effective than the 400 mg ibuprofen dose and had a significantly longer duration of analgesic action. The efficacy of an aspirin-caffeine-codeine-butalbital combination was compared to an acetaminophen-codeine combination and placebo in outpatients who had moderate or severe pain after the surgical removal of impacted third molars. Using a self-rating record, patients rated their pain, relief, anxiety and relaxation hourly for up to 6 hours after medicating. Each active medication was significantly superior to placebo for measures of analgesia and relaxation. Although the butalbital-containing combination provided consistently greater analgesia, the differences between active medications were not statistically significant. The acetaminophen-codeine combination significantly reduced anxiety; however, the butalbital containing combination did not. The results of this study suggest that female patients may have greater efficacy than male patients. All adverse effects were transitory and consistent with the known pharmacologic profiles of the study medications or the backup analgesic. Subjects who had undergone dental impaction surgery and who had moderate to severe postoperative pain were given, under double-blind, randomized conditions, a single dose of either codeine 60 mg, aspirin 650 mg, ibuprofen 400 mg, aspirin 650 mg + codeine 60 mg, ibuprofen 400 mg + codeine 60 mg, or placebo. A total of 249 subjects were included in the statistical analysis. On a report form, subjects recorded pain intensity, pain relief, and side effects hourly for four hours. They also gave an overall impression at the end of the observation period. Analysis of variance and pairwise contrasts were used to analyze the data. For the sum of pain intensity differences, the total of the hourly pain relief scores, and overall impression, there was a significant analgesic effect for codeine, aspirin, and ibuprofen and no significant interaction when they were used in combination. Ibuprofen alone was statistically superior to aspirin and also achieved higher mean scores than the aspirin-codeine combination. The ibuprofen-codeine combination was the most effective treatment for every analgesic parameter, but it was not statistically superior to ibuprofen alone. The possibility exists that the ibuprofen-codeine combination peaked out the sensitivity of the model. There was no notable difference in the frequency or intensity of side effects among the treatment groups, and no subject had to withdraw due to an adverse effect. This study again confirms the superiority of ibuprofen to aspirin and suggests that ibuprofen is at least as effective as an aspirin-codeine combination. Codeine added a small amount of additional analgesia when used in combination with ibuprofen. The analgesic effects of single oral doses of ketoprofen 100 and 300 mg, the combination of aspirin 650 mg plus codeine 60 mg, and placebo were compared under double-blind conditions in 160 hospitalized patients with cancer pain. At baseline and at 30 minutes and hourly for 6 hours after treatment, patients evaluated their pain intensity and pain relief. The 100 mg ketoprofen dose was significantly (P less than 0.05) superior to placebo for all 14 derived efficacy parameters; the 300 mg dose was significantly superior to placebo in all assessments except derived onset of relief. Aspirin plus codeine was significantly (P less than 0.05) superior to placebo for nine of the 14 assessments. No statistically significant differences were observed among active treatments for any of the 14 derived parameters. The number of patients with a "good" response was greatest in the ketoprofen 100 mg group (55%); the numbers of good responders in the aspirin plus codeine (37.5%) and the ketoprofen 300 mg (30%) groups were comparable. The three active treatment groups were not significantly different from each other for patient response. The numbers of patients requiring rescue analgesic were significantly (P less than 0.05) lower for both ketoprofen groups, but not for the aspirin plus codeine group, as compared with the placebo group. Twenty-three percent of the 160 patients reported adverse experiences, but there were no significant differences between the treatment groups in the number or type of experience. These results show that ketoprofen is as effective and well tolerated as aspirin plus codeine in relieving cancer pain. Aspirin (acetylsalicylic acid) and acetaminophen (paracetamol) are frequently used to treat fever and other symptoms of upper respiratory tract infection (URTI). Both are available over the counter for use at the standard recommended doses of 500 and 1000 mg per single use.
                This study investigated the efficacy, safety profiles, and tolerability of aspirin 500 and 1000 mg and acetaminophen 500 and 1000 mg compared with placebo in adult patients with acute febrile URTI of suspected viral origin.
                This was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group trial conducted in Ukraine and Russia. Patients with URTI and acute fever of > or =38.5 degrees C received a single dose of aspirin 500 or 1000 mg, acetaminophen 500 or 1000 mg, or matching placebo. Oral body temperature was measured in the clinic at specified time points up to 6 hours after dosing. The intensity of other symptoms of URTI was rated by patients at baseline and at 2, 4, and 6 hours after dosing (scale from 0 = none to 10 = severe). The primary efficacy measure was the AUC for the change in orally measured body temperature from the time of treatment (baseline) to 4 hours after dosing. Secondary outcome measures included the change in body temperature from baseline to specified time points between 0.5 and 6 hours after dosing, the difference between baseline and the lowest measured body temperature, the time to the lowest measured body temperature, and the intensity of other symptoms of URTI (ie, headache, sinus sensitivity to percussion, sore throat, achiness, and feverish discomfort). Tolerability was monitored by recording of adverse events.
                Three hundred ninety-two patients were enrolled (78 in both aspirin groups, 79 in both acetaminophen groups, 78 in the placebo group). Demographic and baseline characteristics were comparable in the 5 groups; 51% of patients were male, with a mean age of 37.4 years and a mean body weight of 74.3 kg. The AUC values for the change in body temperature 0 to 4 hours after dosing were 3.18 (95% CI, 2.78-3.57) for aspirin 500 mg, 4.26 (95% CI, 3.84-4.68) for aspirin 1000 mg, 3.13 (95% CI, 2.77-3.49) for acetaminophen 500 mg, 4.11 (95% CI, 3.73-4.49) for acetaminophen 1000 mg, and 0.76 (95% CI, 0.38-1.13) for placebo. In terms of the primary efficacy variable, all active treatments were significantly superior to placebo (P < 0.001, 1-sided t test), with no significant differences between them. Reductions in body temperature were significantly greater with the 1000-mg doses of both active treatments compared with the 500-mg doses (P< 0.001, 1-sided t test). The mean maximum temperature reductions were 1.32 degrees C, 1.25 degrees C, 1.67 degrees C,1.71 degrees C, and 0.63 degrees C in the respective treatment groups. Significant reductions were seen in the mean intensity of headache, achiness, and feverish discomfort with all active treatments at most time points (P < 0.001), but not in sinus sensitivity to percussion or sore throat. All treatments were equally well tolerated, and no clinically significant adverse events occurred.
                In this single-dose study, aspirin 500 and 1000 mg and acetaminophen 500 and 1000 mg were more effective against fever and other symptoms of URTI than placebo. Both active treatments showed dose-related efficacy, and there was no significant difference between equal doses of the 2 agents. Safety profiles and tolerability were also comparable between treatments. One hundred sixty-four outpatients with postoperative pain after the removal of impacted third molars were randomly assigned on a double-blind basis, to receive oral doses of flurbiprofen 25, 50, or 100 mg; aspirin 600 mg; or placebo. Using a self-rating record, subjects rated their pain and its relief hourly for 8 hours after medicating. Estimates of sum of pain differences (SPID), peak pain intensity difference (PID), total relief, peak relief, and hours of 50% relief were derived from these subjective reports. All active medications were significantly superior to placebo. Analgesia was similar for flurbiprofen 25 mg and aspirin 600 mg. Flurbiprofen 50 and 100 mg were significantly superior to aspirin for every measure of analgesia except peak PID. There was a significant dose-response regression between flurbiprofen 25 mg and both of the higher dosages. Flurbiprofen 50 and 100 mg did not differ significantly, suggesting a plateau in flurbiprofen's analgesia. The analgesic effect of flurbiprofen was significant by hour 1 and persisted for 8 hours. The frequency of adverse effects was similar for the active medications. A randomized, double-blind, placebo-controlled single oral dose study was done in order to examine whether codeine has an additive analgesic effect to that of paracetamol for moderate and strong postoperative pain after abdominal surgery. The maximum recommended single dose of paracetamol 1000 mg (Paracet) was compared with a combination of a submaximal dose of paracetamol 800 mg plus codeine 60 mg (Paralgin forte) and placebo for pain relief after Caesarean section in 125 patients.
                Visual analogue pain intensity score (VAS 0-100 mm) and categorical pain relief score were recorded for 6 hours after the study drug intake. The main efficacy variables analyzed were: pain intensity difference and summed pain intensity differences during the first 3 and 6 h after study drug intake, total pain relief during the first 3 and 6 h, global evaluation score at the end of the observation period, and time to rescue analgesic.
                Because of protocol violations, 17 patients were excluded from the analysis of effects. Among the 108 patients included in the analysis of analgesic effect, 49 patients had moderate baseline pain (VAS between 40 and 60 mm on a 100 mm scale), and 59 patients had strong baseline pain (VAS more than 60 mm). In patients with strong baseline pain, statistically highly significant differences were documented in efficacy variables between the active drugs and placebo and between the two active drugs. However, in patients with moderate baseline pain, no differences were found between the study drugs in any of the analgesic efficacy variables.
                This study thus confirms that codeine has additive analgesic effect to paracetamol in pain after surgery. Our results show the importance of initial pain intensity in postoperative assessment of analgesic drugs. Assay-sensitivity and test power are increased by selecting patients with sufficiently high initial pain intensity and by comparing groups of patients with identical surgery and similar demographic variables. One-hundred twenty-eight outpatients with postoperative pain after the surgical removal of impacted third molars were randomly assigned, on a double-blind basis, to receive oral doses of ketorolac tromethamine 10 mg, aspirin 650 mg, a combination of acetaminophen 600 mg plus codeine 60 mg, or placebo. Using a self-rating record, subjects rated their pain and its relief hourly for 6 hours after medicating. All active medications were significantly superior to placebo. The acetaminophen-codeine combination was significantly superior to aspirin for peak analgesia. Ketorolac was significantly superior to aspirin for every measure of total and peak analgesia, and significantly superior to acetaminophen-codeine for measures of total effect. The analgesic effect of ketorolac was significant by hour 1 and persisted for 6 hours. Repeat-dose data also suggested that ketorolac 10 mg was superior to aspirin 650 mg and acetaminophen-codeine on the day of surgery. Differences among the active medications were trivial for the postoperative days 1-6 analyses. The frequency of adverse effects was over 4 times greater for acetaminophen-codeine than for ketorolac or aspirin. 1. The efficacy of three different single doses (600, 900 and 1200 mg of soluble aspirin and aspirin tablets) was determined in a randomized placebo-controlled parallel study in 140 patients (70 females) with postoperative pain after removal of impacted third molars. 2. Patients treated with soluble aspirin 600 mg, 900 mg, 1200 mg and aspirin tablet 1200 mg reported significantly less pain (P less than 0.01) throughout the investigation period than those treated with placebo. 3. Overall pain scores after treatment with aspirin tablets 600 and 900 mg did not differ significantly from those after treatment with placebo (P greater than 0.05). 4. On a comparative dose basis, soluble aspirin was significantly more potent (P less than 0.05) than aspirin tablets. The analgesic efficacy of 75, 150, and 300 mg proquazone, a new nonsteroidal antiinflammatory agents, was compared to that of 650 mg aspirin and a placebo in outpatients who had moderate or severe pain following the surgical removal of impacted third molars. Estimates of the relative potency of proquazone to aspirin ranged from 4.9 to 6.2 for total analgesic effect and from 7.7 to 8.4 for peak analgesic effect. Each dosage level of proquazone and aspirin provided significant analgesia compared to placebo and was well tolerated. Adverse effects were transitory and did not appear to be dose related for proquazone. Three hundred fifty outpatients with postoperative pain after the surgical removal of impacted third molars were randomly assigned, on a double-blind basis, to receive a single oral dose of aspirin 650 or 1000 mg, caffeine 65 mg, a combination of aspirin 650 mg with caffeine 65 mg, or placebo. Using a self-rating record, subjects rated their pain and its relief hourly for 6 hours after medicating. Estimates of summed pain intensity difference, peak pain intensity difference, total relief, peak relief, and hours of 50% relief were derived from these subjective reports. All active treatments except caffeine were significantly superior to placebo. Pairwise comparisons indicated the aspirin-caffeine combination was statistically superior to aspirin 650 mg alone for hours of 50% relief among patients who had severe baseline pain. Adverse effects were transitory and none were serious. Acetaminophen (APAP) 1000 mg, APAP 2000 mg, the combination of APAP 1000 mg plus codeine phosphate 60 mg (APAPCOD), and placebo (PBO) were compared in a 6-hour, randomized, single-dose, double-blind, parallel-group analgesic trial. All active treatments were statistically superior (p less than 0.05) to placebo for 4 hours after medication with respect to pain intensity (PI) and pain intensity difference (PID), and up to 3 hours regarding pain relief (PAR). The combination scored better than all other treatments on the summary analgesic efficacy measures sum PI (SUMPI), sum PID (SPID), and total PAR (TOTPAR). The combination was statistically superior to APAP 1000 mg on SUMPI, TOTPAR and maximum PAR (MAXPAR). Acetaminophen 2000 mg showed marginal numerical superiority over 1000 mg for SUMPI, but was not statistically superior for any summary efficacy measure. The 2000-mg dose was numerically inferior to APAPCOD for every summary efficacy measure and statistically inferior regarding SPID and MAXPAR. We concluded that codeine 60 mg added to acetaminophen 1000 mg offers analgesic advantages, and acetaminophen reaches an analgesic ceiling effect at 1000 mg using the dental pain model. The analgesic efficacy of fendosal, a new nonsteroidal anti-inflammatory agent structurally related to salicylic acid, was compared with that of aspirin and placebo in 100 patients with postpartum uterine pain in a single oral dose, parallel, stratified, randomized, double-blind design. With 650 mg aspirin and with 200 or 400 mg fendosal, but not with 100 mg, analgesic effects, as measured subjectively by mean pain intensity scores, began within 1 hr and had similar time-effect patterns for the first 4 or 5 hr. Thereafter with the 2 higher doses of fendosal analgesia contimued to increase, reaching a peak at 6 hr (p less than 0.05) and persisting beyond 7 hr (p less than 0.01), whereas there was no aspirin analgesia after the fifth hour. With 100 mg fendosal time of onset tended to be delayed 2 hr or more, and duration was short. The most effective treatment (largest mean 7-hr sum of pain intensity difference [SPID] scores) was 400 mg fendosal (p less than 0.01); 200 mg fendosal was rated second (p less than 0.01), 650 mg aspirin, third (p less than 0.05), 100 mg fendosal, fourth, and placebo, fifth. There was no significant side effects. These results demonstrate the efficacy of single doses of fendosal as well as the dose-dependent magnitude and time course of effects on postpartum uterine pain. Amfenac, an arylacetic acid derivative, is a new investigational, nonsteroidal antiinflammatory agent that has exhibited analgesic properties superior to those of phenylbutazone in animals. This double-blind, randomized, parallel study was an early clinical trial to evaluate the analgesic efficacy of one oral dose of amfenac 100 mg compared to aspirin 600 mg and placebo in 120 subjects with moderate to severe pain after extraction of impacted molar teeth. Self-evaluated subjective pain intensity and relief reports for 4 hours were used as indexes of response. Analgesic effects of amfenac were significantly superior to those of placebo (p less than 0.001) and aspirin (p less than 0.05) by most measurements. Aspirin 600 mg was superior to placebo based on total pain relief and global scores (p less than 0.05). Compared with aspirin 600 mg, amfenac 100 mg provided greater and faster analgesia, lasting at least for 4 hours. Ordinal pain intensity scores correlated well with the visual pain analog scale. Seven (17.5%) patients taking amfenac compared to 5 (12.5%) taking placebo reported minor adverse effects). The analgesic efficacy of flurbiprofen 25 mg and 50 mg compared with aspirin 650 mg and placebo (lactose) was evaluated. Subjects were 164 dental outpatients undergoing the surgical removal of impacted teeth. Each subject received a single dose of study medication and was evaluated hourly for six hours. Aspirin was superior to placebo in all measures of analgesic efficacy, and both dosages of flurbiprofen were superior to aspirin. To compare the efficacy of mouth-dispersible aspirin 900 mg and placebo in the treatment of migraine.
                Aspirin is widely accepted as an effective therapy for migraine. Previous studies have indicated that gastric stasis and delayed gastric emptying, which occur during migraine attacks, delay aspirin absorption. Mouth-dispersible formulations are considered to be more quickly absorbed than solid formulations and, therefore, may be more effective in treating migraine.
                Randomized, double-blind, placebo-controlled, crossover study in four specialized migraine clinics in the United Kingdom.
                One hundred one patients diagnosed with migraine (according to the International Headache Society diagnostic criteria) participated in the study. Patients received either single doses of mouth-dispersible aspirin (3 x 300 mg) or placebo for moderate pain in the treatment of two migraine attacks. Rescue medication could be taken after 2 hours, if required. The primary efficacy parameter was response to therapy at 2 hours posttreatment. Other efficacy parameters were response to treatment, pain-free, and pain intensity at all other time points. Functional disability, nausea, vomiting, photophobia, phonophobia, symptom relief, patient and investigator global evaluation, use of rescue medication, headache recurrence, and palatability and convenience were also recorded.
                Of 101 patients, 73 took both treatments. At 2 hours, 48% of patients taking mouth-dispersible aspirin responded, compared to only 19% taking placebo (P =.0005). Mouth-dispersible aspirin was significantly better than placebo for response to treatment (P<.05) and pain intensity difference (P<.01) at all time points from 30 minutes posttreatment; for pain-free (P<.05) and use of rescue medication (P<.01) from 3 hours posttreatment; for headache recurrence (P<.05); and for patients' and investigators' global evaluations of efficacy (P =.0001 in both cases).
                Mouth-dispersible aspirin 900 mg is effective compared with placebo for the treatment of moderate migraine head pain, with relief seen from as early as 30 minutes after taking medication. Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300 mg) were taken as required as 'rescue' medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo (P = 0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group. Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects (P = 0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain. The analgesic efficacy of oral naproxen and its sodium salt was compared with that of aspirin and codeine in two separate trials involving 140 and 90 patients, respectively, with postpartum uterine pain in a single-dose, parallel, stratified, randomized, placebo-controlled, double-blind design. With 300 or 600 mg naproxen and with 275 mg naproxen sodium, significant analgesia, measured subjectively by pain intensity differences (PID), was prolonged at least 7 or 8 hr; onset tended to be delayed 2 hr or more. With 650 mg aspirin analgesia began within 1 hr and continued until the fifth hour, while with 60 mg codeine responses were indistinguishable from placebo responses throughout the 8-hr time course. Although time-effect patterns with naproxen sodium and aspirin were different, summed analgesic effects (SPID) showed equal efficacy and superiority over placebo (p less than 0.005). With each of the 2 doses of naproxen, SPID separation from placebo was comparable to that above (p less than 0.02 and 0.005, respectively), but analgesic dose response, though measurable, was not significant. Side effects were not significant with any of the treatments. It appears that naproxen and naproxen sodium are analgesics with efficacy equal to aspirin and may prove to be rational substitutes for currently available analgesics in some painful states in which longer pain relief would be desireable. Flurbiprofen (Ansaid, Upjohn), a substituted phenyl propionic acid, is a new analgesic/anti-inflammatory agent. To evaluate its relative efficacy in noninflammatory pain, 159 hospitalized women with moderate or severe postpartum uterine cramps were given single oral doses of 50 mg of flurbiprofen, 650 mg of aspirin, 60 or 120 mg of codeine sulfate, or placebo in a parallel, stratified, randomized block, placebo-controlled, double-blind trial. Patients rated pain intensity, pain relief, and side effects in uniform interviews for six hours after treatment. All measures of peak and summed analgesia exhibited significant differences among the five treatments. Flurbiprofen and aspirin showed the greatest analgesic response and were significantly superior to placebo. Results of codeine treatment were equivocal with no evidence of a positive dose response. Side effects were unremarkable except for dizziness and drowsiness after the 120-mg codeine dose. These findings suggest that flurbiprofen as an analgesic for patients with postpartum uterine pain is equivalent to aspirin and superior to codeine. Utilizing 3 different methods for analyzing the results, a single dose double-blind crossover study of the effectiveness of 5 analgesics and placebo against the pain of rheumatoid synovitis in 30 subjects showed all active drugs superior to placebo by 1 analysis; aspirin, codeine and acetaminophen superior to both placebo and propoxyphene by a second; and aspirin alone superior to placebo and propoxyphene by a third. More side effects were reported from pentazocine than from other agents. The analgesic efficacy of etodolac for 161 patients reporting moderate to severe pain after oral surgery was evaluated. The patients were given single oral doses of one of the following test drugs--aspirin, 650 mg; etodolac, 50 mg; or etodolac, 200 mg--or placebo. There were at least 39 patients in each drug group. After medication, patients recorded pain intensity and pain relief at half-hour intervals for the first hour and then hourly for up to eight hours. Pain intensity differences, total pain relief, onset of analgesia, and each patient's overall opinion of the drug were analyzed. Time--effect curves were derived from the pain relief and pain intensity difference scores. Analgesic effects produced by both doses of etodolac were comparable with those of 650 mg of aspirin. All active drugs were significantly more effective than placebo, and the 200-mg dose of etodolac provided an earlier onset and longer duration of analgesia than the other test drugs. Two-hundred and one outpatients with postoperative pain following oral surgery were randomly assigned, on a double-blind basis, a single oral dose of diflunisal (250, 500, or 1000 mg), aspirin (650 mg), or placebo. Using a self-rating record, the subjects rated their pain and its relief hourly for 12 hours after medication. Measures of peak and total analgesia were derived from the patients' subjective reports. Diflunisal 250 and 1000 mg were significantly superior to aspirin for every measure of total and peak analgesia; the 500-mg diflunisal dose was significantly superior to aspirin for measures of total analgesia only. All doses of diflunisal were significantly superior to aspirin and placebo at each hour from hour 3 through hour 12. Approximately 60 per cent of the patients treated with diflunisal completed the 12-hour observation period without the need for additional analgesic therapy. Adverse effects were mild and transitory and occurred in less than 10 per cent of the patients. Fluradoline (150 or 300 mg), a novel tricyclic with both antidepressant and analgesic properties in animals, was compared with aspirin, 650 mg, and placebo when given orally for postoperative orthopedic pain in a double-blind, single-dose, parallel-group study. Analgesic measurements were made by two trained nurse observers using standard verbal rating and visual analogue scales. Aspirin was statistically superior to placebo on all analgesic measures, demonstrating assay sensitivity. Fluradoline, 300 mg, was distinguished from placebo and fluradoline, 150 mg, but not from aspirin, 650 mg. Overall, fluradoline, 300 mg, was equivalent to aspirin, 650 mg. Fluradoline, 300 mg, produced a significant elevation in mood score. Neither aspirin, 650 mg, nor fluradoline caused untoward side effects, but fluradoline, 300 mg, increased blood pressure. The safety and efficacy of single oral doses of oxaprozin (1200 mg), aspirin (650 mg), and placebo were compared in an 8-hour double-blind study of 105 patients with moderate to severe post-operative dental-surgical pain. As measured by mean and cumulative mean scores obtained with the pain intensity and verbal pain relief scales, both active drugs produced significantly (p less than 0.05) more analgesia than did placebo. A significantly (p less than 0.05) greater proportion of patients reported effective (moderate or better) pain relief in the oxaprozin and aspirin groups than in the placebo group at 2, 3, and 4 hours; significant (p less than 0.05) differences between the oxaprozin and placebo groups continued for the entire 8 hours. Oxaprozin provided more pain relief than aspirin during the latter part of the study. There were no statistically significant differences, however, in any of the efficacy assessments between the oxaprozin and aspirin groups. By the end of the 8-hour observation, significantly (p less than 0.01) fewer patients taking oxaprozin (27%) than placebo (60%) were considered treatment failures and needed a replacement analgesic. Of those taking aspirin, 41% were treatment failures, not statistically different from the proportion of treatment failures with placebo. Adverse effects were infrequent, mild, comparable between the active treatment and placebo groups, and not definitely related to drug therapy. Oxaprozin provided greater pain relief than placebo and was comparable to aspirin during the first 4 hours of the evaluation; thereafter, greater pain relief occurred in the oxaprozin-treated group than either the aspirin or placebo-treated group. To determine the relative analgesic efficacy of ibuprofen 400 mg and acetaminophen 1000 mg, we conducted a single-dose, double-blind, placebo-controlled, randomized clinical trial using a standard assay for analgesic agents, the dental pain model. At regular intervals over 6 hours, 184 patients who had undergone dental impaction surgery rated pain intensity and relief on categorical scales and pain half-gone on a dichotomous nominal scale; a categorical overall evaluation was completed at the end of 6 hours. Both active agents were effective compared to placebo. Ibuprofen 400 mg was more effective than acetaminophen 1000 mg for Sum Pain Intensity Difference (SPID), Total Pain Relief (TOTPAR), sum pain half-gone, and overall evaluation (P less than .05 to P less than .001). The time-effect curves demonstrated a greater peak effect and longer duration of action for ibuprofen 400 mg compared to acetaminophen 1000 mg. Side effects were reported in five ibuprofen patients, 11 acetaminophen-treated patients, and seven placebo patients. Based on the results of this clinical study, we conclude that ibuprofen 400 mg is a safe and more effective analgesic than acetaminophen 1000 mg for patients with acute pain.
Aspirin is an effective analgesic for acute pain of moderate to severe intensity. High doses are more effective, but are associated with increased adverse events, including drowsiness and gastric irritation. The pain relief achieved with aspirin was very similar milligram for milligram to that seen with paracetamol. There was no change to the conclusions in this update.