The efficacy of etodolac for patients with pain following oral surgery. Conventional and extended-release etodolac for postsurgical dental pain. Evaluation of ketorolac, ibuprofen, acetaminophen, and an acetaminophen-codeine combination in postoperative oral surgery pain. Etodolac in postsurgical pain: a double-blind dose-ranging efficacy study with aspirin and placebo. Comparison of etodolac, aspirin and placebo for pain after oral surgery. The effectiveness of 100 and 200 mg etodolac (Ultradol), aspirin, and placebo in patients with pain following oral surgery. Comparison of etodolac, zomepirac, and placebo for relief of pain after oral surgery.
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. This double-masked, parallel-group, randomized study compared the analgesic efficacy and tolerability of a single investigational 1200-mg dose of extended-release etodolac with those of a single 400-mg dose of extended-release etodolac and twice-daily doses of conventional etodolac 200 and 400 mg and placebo given 8 hours apart in 237 patients with moderate or severe postoperative pain following surgical removal of > or = 2 impacted third molars. Both doses of conventional etodolac and the 1200-mg dose of extended-release etodolac were significantly more effective on all summary analgesic measures than placebo (P < 0.05). Conventional etodolac had an onset of analgesic activity within 45 (400 mg) to 60 (200 mg) minutes and an analgesic duration of 5 to 6 hours. Extended-release etodolac 1200 mg had an onset of action within 60 minutes and an analgesic duration of 12 to 24 hours. At hours 2 and 3, conventional etodolac 400 mg was significantly more effective than the other treatments; from hours 6 through 12, extended-release etodolac 1200 mg was significantly more effective than the other treatments (both, P < 0.05). No serious adverse events were observed in this study, with an incidence of side effects in the active etodolac groups no different than that with placebo. Extended-release etodolac 1200 mg has a prolonged analgesic duration and an acceptable side-effect profile in the oral surgery pain model. Two-hundred six 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 and 20 mg, ibuprofen 400 mg, acetaminophen 600 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. Analgesia was similar for ketorolac 10 and 20 mg and ibuprofen 400 mg; however, these treatments were superior to acetaminophen alone and the acetaminophen-codeine combination. The analgesic effect of each active medication was significant by hour 1 and persisted for 5-6 hours. The data suggest a plateau in ketorolac's analgesic efficacy at the 10-mg level. Repeat-dose data indicated that on the day of surgery ketorolac 10 and 20 mg and ibuprofen 400 mg were superior to acetaminophen 600 mg; ketorolac 20 mg was also superior to acetaminophen-codeine. Differences among active medications were not significant when data for the entire postoperative period (days 0-6) were evaluated. The frequency of adverse effects was similar for the active medications. A study was conducted to compare the analgesic activity of single oral doses of etodolac (25, 50, 100, 200, and 400 mg) with 650 mg aspirin and placebo. A total of 146 patients with moderate or severe pain from orthopedic or urologic interventions received one of the test medications 13-25 h after the beginning of surgery and according to a randomized allocation balanced as to initial pain intensity. Data for pain intensity and pain relief were collected at 1/2 h and then hourly for 8 h. Vital signs and adverse reactions were also recorded. One hundred and forty-two patients completed the study: four were excluded because of protocol deviations. The average response to 100, 200, and 400 mg of etodolac was superior to that of placebo. On the basis of SPID, TOTPAR, and duration of analgesia, 400 mg etodolac was also significantly more effective than 650 mg aspirin. Mild side effects probably or possibly related to etodolac were reported by three patients. This study provides evidence that etodolac in doses of 100 mg and higher is an effective and well-tolerated analgesic. Single oral doses of etodolac 50, 100 and 200 mg were compared with aspirin 650 mg and placebo in a double-blind, parallel group study of 189 outpatients reporting moderate or severe pain after oral surgery. Overall efficacy of test drugs was evaluated by sum of pain intensity difference (SPID) scores and total pain relief (TOTPAR) scores over 0.5-3, 0.5-6, 0.5-8 and 0.5-12 hours. Etodolac 200 mg provided significantly greater analgesia than aspirin by these measurements over all SPID and all but one TOTPAR interval, and was significantly more effective than placebo over all intervals. Etodolac 100 mg was superior to aspirin for SPID 0.5-8 and 0.5-12 hours, and superior to placebo for both SPID and TOTPAR over all time intervals. Onset of analgesia for etodolac 100 mg, 200 mg and aspirin was 1 hour or less for the majority of patients in each group; 42% receiving etodolac 200 mg reported onset of analgesia within 0.5 hour. Duration of analgesia for etodolac 200 mg appeared twice that of aspirin. A significant positive dose-response relationship was obtained for the three doses of etodolac. A low frequency of side effects was observed in all treatment groups. 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. A double-blind, randomized study of 137 patients compared the effectiveness of single doses of etodolac, 200 and 400 mg, zomepirac, 100 mg, and placebo in relieving moderate to severe pain following third molar extractions. Throughout the 12-hour evaluation period, doses of both etodolac and zomepirac were significantly superior to placebo for total analgesic effect, as measured by the sum of pain intensity difference (SPID) and sum of pain relief (TOTPAR) scores. However, there were no significant differences among the active drugs. It was concluded that etodolac, 200 and 400 mg, provides analgesic efficacy comparable to that of zomepirac, 100 mg, and superior to that of placebo.
Etodolac 200 mg may be a useful analgesic in postoperative pain, with efficacy similar to paracetamol 1000 mg and celecoxib 200 mg. Higher doses may provide analgesia equivalent to more commonly used drugs, such as ibuprofen 400 mg, naproxen 500 mg and diclofenac 50 mg.