A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation. Low-level infrared laser therapy in chemotherapy-induced oral mucositis: a randomized placebo-controlled trial in children. Effect of low level helium-neon (He-Ne) laser therapy in the prevention & treatment of radiation induced mucositis in head & neck cancer patients. Patient-controlled analgesia vs. conventional intramuscular analgesia following colon surgery. Patient-controlled analgesic administration. A comparison of steady-state morphine infusions with bolus doses. Comparison of a patient-controlled analgesia system with continuous infusion for administration of diamorphine for mucositis. Adolescents use patient-controlled analgesia effectively for relief from prolonged oropharyngeal mucositis pain. Influence of low-energy laser in the prevention of oral mucositis in children with cancer receiving chemotherapy. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Patient-controlled analgesia in children and adolescents: a randomized, prospective comparison with intramuscular administration of morphine for postoperative analgesia. The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: results from two prospective studies. Comparison between patient-controlled analgesia and intramuscular meperidine after thoracotomy. Self-administration of morphine in bone marrow transplant patients reduces drug requirement. Patient-controlled analgesic infusions: alfentanil versus morphine. A statistical model for pain in patient-controlled analgesia and conventional intramuscular opioid regimens. Patient-controlled analgesia for mucositis pain in children: a three-period crossover study comparing morphine and hydromorphone. Efficacy and costs of patient-controlled analgesia versus regularly administered intramuscular opioid therapy. A randomized comparison of patient-controlled versus standard analgesic requirements in patients undergoing cholecystectomy. Efficacy of topical phenytoin on chemotherapy-induced oral mucositis; a pilot study. Patient-controlled analgesia: a controlled trial. Patient-controlled analgesia: a comparison with nurse-controlled intravenous opioid infusions. [Venous leg ulcers: no improvement of wound healing with 685-nm low level laser therapy. Randomised, placebo-controlled, double-blind study]. Efficacy of patient-controlled versus conventional analgesia for postoperative pain. Low-energy He/Ne laser in the prevention of radiation-induced mucositis. A multicenter phase III randomized study in patients with head and neck cancer. Posterior capsule opacification after phacoemulsification in patients with postoperative steroidal and nonsteroidal treatment. Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. Comparison of laser acupuncture and metoclopramide in PONV prevention in children.
Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.
                Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm2. Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.
                The 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.
                While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM. Oral mucositis (OM) is one of the most frequent complications of chemotherapy for which there is no standard therapy; treatment is mostly conservative. This study was conducted to determine whether low-intensity laser therapy (LLLT) can reduce the duration of chemotherapy-induced OM.
                A placebo-controlled randomized trial was carried out using LLLT or placebo (sham treatment). Children and adolescents with cancer receiving chemotherapy or hematopoietic stem-cell transplantation between October 2005 and May 2006 were eligible as soon as they developed OM. Patients received intervention for 5 days. The LLLT group was treated with laser GaAlAs, wavelength (lambda): 830 nm (infrared), power: 100 mW, dose: 4 J/cm, and placebo group underwent sham treatment. The grade of OM was clinically assessed by the National Cancer Institute, Common Toxicity Criteria scale.
                Twenty-one patients developed OM and were evaluable for analysis; 18 (86%) patients had a diagnosis of leukemia or lymphoma and 3(14%) had solid tumors. The mean age was 8.2 (+/-3.1) years. Nine patients were randomized in the laser group and 12 in the placebo-control group. Once OM was diagnosed, the patients had daily OM grading assessments before laser or sham application and thereafter until complete healing of the lesions. On day 7 after OM diagnosis, 1/9 of patients remained with lesions in laser group and 9/12 of patients in the placebo-control group (P=0.029). In the laser group, the mean of OM duration was 5.8+/-2 days and in the placebo group was 8.9+/-2.4 days (P=0.004).
                Our study has shown evidence that laser therapy in addition to oral care can decrease the duration of chemotherapy-induced OM. Our results confirm the promising results observed in adult cancer patients and should encourage pediatric oncologists to use laser therapy as first-line option in children with chemotherapy-induced OM. Oral mucositis is a common debilitating complication of radiotherapy occurring in about 60 per cent of cancer patients. Considerable buccal toxicity of radiotherapy or chemotherapy in cancer patients to become discouraged and can affect their quality of life. In addition, such toxicity can alter the treatment plan. At present, there is no clinically appropriate prophylaxis efficacious antidote for mucositis. The low level laser (LEL) appears to be a simple, non-traumatic technique for the prevention and treatment of radiation induced mucositis. Therefore the present study was carried out to find out the effect of low-level helium-neon (He-Ne) laser in the prevention and treatment of radiation induced mucositis in head and neck cancer patients.
                The patients with carcinoma of oral cavity with stages II-IV a being uniformly treated with curative total tumour dose of 66 Gy in 33 fractions over 6 wk were selected for the study. The patients were divided based on computer generated randamosization into laser (study group) and control groups with 25 patients in each group. Both study and control groups were comparable in terms of site of the lesion, stage of the cancer and histology. The study group patients were treated with He-Ne laser (wavelength 632.8 nm and output of 10mW) and control group patients were given oral analgesics, local application of anaesthetics, 0.9 per cent saline and povidine wash during the course of radiotherapy.
                All patients tolerated the laser treatment without any adverse effect or reactions. The result showed a significant difference in pain and mucositis (P<0.001) between the two groups. At the end of radiotherapy (after 6 wk) mean pain sure and mucositis grade were significantly lower (P<0.001) in the study group compared to control.
                The low-level He-Ne laser therapy during the radiotherapy treatment was found to be effective in preventing and treating the mucositis in head and neck cancer patients. Further studies need to be done on a larger sample to find the mechanism. Though patient-controlled analgesia (PCA) has been in use for over a decade, it has been popularized only recently. Conventional techniques of intermittent intramuscular (IM) administration of analgesia have fallen short of meeting the needs of patients following major abdominal surgery. This has prompted a search for methods to improve postoperative pain management. Though PCA has been accepted in many hospitals, few studies comparing conventional IM administration of morphine with PCA have been performed. A prospective randomized study comparing IM- and PCA-administered morphine in 62 patients undergoing colon surgery was performed. A comparison of the efficacy of analgesia and extent of sedation using these approaches shows that PCA allows for analgesia with less sedation and less drug requirement than that of IM administration. No differences were noted in postoperative duration of ileus, duration of hospitalization, and total hospital costs. This study confirms the safety and efficacy of PCA, and should be considered the current optimal method of controlling pain following major colonic surgery. The authors have shown previously that bone marrow transplant (BMT) patients who self-administered bolus doses of morphine gained equal oral mucositis pain relief while using less drug compared with similar patients receiving morphine by staff-controlled continuous infusion. In a follow-up study they compared the efficacy and side effects of morphine in two groups of marrow transplant patients who controlled their own analgesic administration either by conventional bolus-dose, patient-controlled analgesia (PCA) or by adjusting the rate of continuous morphine infusion to increase or decrease their plasma morphine concentration. Patients controlling their morphine infusion rates (pharmacokinetically based patient-controlled analgesia [PKPCA] group) obtained more relief from oral mucositis pain than did patients using conventional PCA. Patients in the PKPCA group used more morphine than PCA patients and achieved superior pain relief without significant increases in side effects (e.g., nausea, mood changes, sedation). The authors conclude that PKPCA improves the management of prolonged, severe pain in marrow transplant patients and that this approach to patient-controlled analgesia may be useful in other types of persistent pain. Mucositis remains an important problem following BMT and may delay discharge from hospital. Patient-controlled analgesia (PCA) systems have been reported to be of benefit in controlling BMT-associated mucositis. The present study comprised 65 patients (age range 16-68 years; 19 allografts, 29 peripheral blood stem cell autografts and 17 autologous bone marrow). Subjects were prospectively randomised to receive intravenous diamorphine for pain relief either by conventional continuous infusion (CI) or by PCA, using a Medex Walkman 440 delivery system. Each patient assessed his/her pain control and nausea daily by a visual analogue scale. Twenty-two patients did not require any diamorphine. Four patients required diamorphine for pain other than mucositis, and four patients failed PCA control. Of 35 assessable cases, no difference in pain control was noted between CI and PCA. However, PCA-controlled patients required significantly less diamorphine than CI controlled patients (mean, 131 +/- 23 mg for PCA vs 296 +/- 40 mg for CI; P = 0.001), and PCA required fewer days of diamorphine than CI (mean, 7.17 +/- 0.66 days for PCA, 9.00 +/- 0.65 days for CI; P = 0.03). Side-effects were minimal and equivalent in the two arms. The findings suggest that PCA and CI offer equivalent control of the pain of BMT-associated mucositis, but PCA requires less total consumption and duration of diamorphine therapy. We compared patient-controlled analgesia (PCA) and continuous infusion (CI) morphine delivery in a randomized controlled trial in adolescents during oropharyngeal mucositis pain after bone marrow transplantation. Results from 20 patients who completed 7 or more days on study (10 PCA, 10 CI) were evaluated. The group means for age, weight and height were comparable. Daily measures were morphine intake, self-report of pain intensity and side effect scores. Over 10 study days, the mean cumulative morphine dose to subjects in each group was 4.94 mg/kg (PCA) vs. 12.17 mg/kg (CI); the difference is significant (P less than 0.01). No significant differences were found between the groups for patient ratings of pain intensity or side effect scores despite the large difference in mean morphine intake, but the PCA group tended to report less intense sedation and less difficulty concentrating. Adolescents can use PCA effectively and safely for 1-3 weeks. Morphine intake of adolescent patients using PCA morphine intake is significantly lower than that of similar patients receiving staff-controlled CI. This study assessed the use of low-energy laser in the prevention or reduction of the severity of oral mucositis.
                A randomized clinical trial was carried out. Patients from 3 to 18 years of age treated with chemotherapy or hematopoietic stem-cell transplantation between May, 2003 and February, 2005 were eligible. The intervention group received laser application for 5 days following the start of chemotherapy. The grade of oral mucositis was assessed by the WHO per NCI-CTC common toxicity criteria and the assessments were made on days 1, 8 and 15 by a trained examiner blind to the intervention.
                Sixty patients were evaluable for analysis; thirty-nine (65%) were males, 35 (58%) patients had a diagnosis of leukemia or lymphoma, and 25 (42%) had solid tumors. The mean age was 8.7 +/- 4.3 years. Twenty-nine patients were randomized in the laser group and 31 in the control group. On day 1, no patients presented with mucositis. On day 8, of 20 patients (36%) who developed mucositis, 13 of them were from the laser group and 7 from the control group. On day 15, of 24 patients (41%) who developed mucositis, 13 of them were from the laser group and 11 from the control group. There was no significant difference between groups concerning the grades of mucositis on day 8 (P = 0.234) or on day 15 (P = 0.208).
                This study showed no evidence of benefit from the prophylactic use of low-energy laser in children and adolescents with cancer treated with chemotherapy when optimal dental and oral care was provided. Given the inherent side effects associated with both opioid and nonopioid analgesic drugs, a nonpharmacologic therapy that could decrease the need for analgesic medication would be valuable. We designed a sham-controlled study to assess the effect of the intensity of transcutaneous acupoint electrical stimulation (TAES) on postoperative patient-controlled analgesia (PCA) requirement for hydromorphone (HM), the incidence of opioid-related side effects, and the recovery profile after lower abdominal surgery. One hundred one healthy consenting women undergoing lower abdominal procedures with a standardized general anesthetic technique were randomly assigned to one of four postoperative analgesic treatment regimens: Group I (n = 26) PCA only; Group II (n = 25), PCA + sham-TAES (no electrical stimulation); Group III (n = 25), PCA + low-TAES (4-5 mA of electrical stimulation); Group IV (n = 25), PCA + high-TAES (9-12 mA of electrical stimulation). The PCA device was programmed to deliver HM, 0.2-0.4 mg intravenously boluses "on demand," with a minimum lockout interval of 10 min. The TAES skin electrodes were placed at the Hegu acupoint on the nondominant hand and on both sides of the surgical incision. The TAES frequency was set in the dense-and-disperse mode, alternating at 2 Hz and 100 Hz every 3 s, with stimulation of the hand and incision alternated every 6 s. The patients in Groups II-IV were instructed to use TAES every 2 h for 30 min while awake. After discontinuation of PCA, oral pain medications were administered on demand. The postoperative PCA-HM requirement, pain scores, opioid-related side effects, and requirements for antiemetic and antipruritic medication were recorded. High-TAES decreased the HM requirement by 65% and reduced the duration of PCA therapy, as well as the incidence of nausea, dizziness, and pruritus. Low-TAES produced a 34% decrease in the HM requirement compared with only 23% in the "sham" TAES group. We conclude that high-TAES produced a significant decrease in the PCA opioid requirement and opioid-related side effects after low intraabdominal surgery. A randomized, prospective trial of patient-controlled analgesia (PCA), that is, a method of analgesia administration involving a computer-driven pump activated by patients to receive small doses within defined limits was performed in 82 children and adolescents after major orthopedic surgery to compare (1) intramuscularly administered morphine, (2) PCA morphine and (3) PCA morphine with a low-dose continuous morphine infusion (PCA-plus). Patients receiving PCA and PCA-plus had lower pain scores and greater satisfaction than patients receiving intramuscularly administered morphine. The three groups used equal amounts of morphine and most measures of recovery were identical in the groups. In particular, PCA and PCA-plus did not increase the incidence of opioid-related complications, and patients receiving PCA-plus were less sedated than patients receiving intramuscular therapy. We conclude that PCA and PCA-plus are safe and effective methods of pain relief in children and adolescents after orthopedic surgery, are better accepted than intramuscular injections, and do not increase perioperative morbidity. Low-energy laser (LEL) treatment has been suggested as an effective and safe method to prevent and/or treat oral mucositis induced by chemotherapy and/or radiotherapy; however, it has not gained wide acceptance so far.
                We conducted two clinical trials testing the LEL technique: firstly, as a secondary prevention in patients with various solid tumors treated with chemotherapy who all developed severe mucositis after a previous identical chemotherapy and, secondly, as therapeutic intervention (compared to sham illumination in a randomized way) in patients with hematological tumors receiving intensive chemotherapy and having developed low-grade oral mucositis.
                We entered 26 eligible patients in the first study and 36 were randomized in the second study. The success rate was 81% (95%CI = 61-93%) when LEL was given as a preventive treatment. In the second study, in patients with existing lesions, the therapeutic success rate was 83% (95%CI = 59-96%), which was significantly different from the success rate reached in the sham-treated patients (11%; 95%CI = 1-35%); the time to development of grade 3 mucositis was also significantly shorter in the sham-treated patients (p < 0.001).
                Our results strongly support the already available literature, suggesting that LEL is an effective and safe approach to prevent or treat oral mucositis resulting from cancer chemotherapy. A prospective randomized controlled study was performed to assess the efficacy and safety of patient-controlled analgesia (PCA) in patients undergoing thoracotomy. This method was compared with a conventional pain management technique consisting of regularly scheduled im injections of analgesics. Forty adult patients were randomly assigned to receive intravenous PCA or im meperidine treatment over a 48-hr period after surgery. Care was taken to optimize analgesia in patients of both groups. The McGill Pain Questionnaire, visual analogue and verbal-numeric scales were administered at regular intervals to measure various components of the patients' pain experience, degree of pain relief, adverse side effects and overall treatment efficacy. Functional recovery after surgery was also examined. The results showed good and comparable analgesia with both pain-control methods. However, a greater number of patients receiving im injections required dosage adjustments than in the PCA group. Patients' and nurses' evaluations of overall treatment efficacy also favoured PCA treatment. There were no major group differences in the side effect profile. Recovery pattern was also comparable in the two groups except for the length of hospitalisation. There were fewer long-stay patients in the PCA than in the im group. Meperidine intake was similar in both groups but considerable interpatient variation was seen. In conclusion, PCA is a safe, effective and individualized treatment method for controlling pain after thoracotomy. There appears to be some clinical advantages of PCA over im dosing regimens for analgesia after thoracotomy. Bone marrow transplant recipients were randomly assigned to receive morphine by either continuous infusion (32 patients) or self-administration of small boluses (patient-controlled analgesia (PCA), 26 patients) for control of chemoradiotherapy-induced oral mucositis pain. All patients received morphine for a minimum of 9 days and most required morphine for at least 14 days. Patients rated their pain and side-effect intensity daily using visual analogue scales. Patient pain ratings did not differ between the groups although PCA patients used only 53% as much morphine as the continuous infusion group. Tolerance did not develop in the PCA group; in patients receiving continuous infusion morphine dosage continued to increase throughout the study while pain scores remained constant, indicating that tolerance had developed. Nausea, alertness and respiratory rate measurements did not differ between groups. PCA appeared more effective than the hospital staff determined treatment at delivering the least amount of morphine required to produce maximal pain relief. Patients self-administering morphine did not appear to restrict morphine intake in order to minimize opioid side-effects. Previously, we found that cancer patients using a pharmacokinetically based patient-controlled intravenous infusion system (PKPCA) to regulate their own morphine infusion rates achieved more relief from oral mucositis pain than similar patients using morphine by bolus-dose PCA. In this study, we employed the PKPCA system to compare efficacy and side-effect intensities of 2 mu-selective opioid analgesics, alfentanil and morphine, in bone marrow transplant (BMT) patients self-administering the drugs to relieve pain from oral mucositis. Patients using morphine by PKPCA obtained more pain relief than patients regulating their own alfentanil infusions during the first 4 days of continuous opioid infusion therapy. Side-effect intensities did not differ between the 2 study groups. In contrast to patients using morphine for 4-14 days, those receiving alfentanil by PKPCA required unexpectedly high plasma concentrations of the drug to obtain equivalent pain relief. Our results indicate that either the relative potencies of these 2 mu-selective opioids differ from previous estimates or analgesic tolerance developed to alfentanil but not to morphine. We conclude that alfentanil has similar efficacy in control of prolonged pain in BMT patients, but the utility of alfentanil in long-term pain management may be limited by relatively rapid tolerance onset. A statistical model was developed: 1) to compare the efficacy of patient-controlled analgesia (PCA) and traditional intramuscular (IM) opioids for pain relief in 40 patients after total knee replacement and, 2) to evaluate pain cycles associated with each technique. Hourly visual analog pain scores were subjected to two-way analysis of variance (ANOVA) and time-series analysis. Hourly verbal analog pain scores were used to determine predominant pain levels. According to ANOVA, PCA was no more effective than were IM opioids. Time-series analyses documented a complete cycle of pain every 5.3 hours in patients receiving IM opioids but no pain cycle with use of PCA. Analysis of PCA verbal analog scores demonstrated self-administration of opioids to "moderate" levels of pain relief with use of PCA, not to complete analgesia. These results suggest that certain patients may not envision complete postoperative analgesia as being possible. Hence, they self-administer opioids for pain relief with PCA according to their expectations. Population characteristics may modify PCA efficacy. These characteristics should be delineated and the use of PCA targeted to appropriate patients. (1) To test the safety and efficacy of a clinical protocol for administering opioid by using patient-controlled analgesia (PCA) for the management of mucositis pain in children after bone marrow transplantation, (2) to compare the efficacy, side-effect profile, and potency ratio of morphine with those of hydromorphone by using PCA as the method of opioid administration, and (3) to obtain pharmacokinetic data on hydromorphone and morphine in this population of children.
                In this double-blind, three-period crossover study, patients were randomly assigned to receive either morphine (group 1) or hydromorphone (group 2) initially by means of PCA on days 1, 2, and 3 (period 1), to be followed on days 4, 5, and 6 (period 2) with the alternative opioid, followed by the opioid used at the commencement of the study on days 7, 8, and 9 (period 3). A clinical protocol for calculating the PCA commencement opioid dose and subsequent opioid-dose escalation was tested by measures of safety and efficacy. Measures of pain intensity and opioid side effects were made during the three periods. On the last study day (day 10), patients received a continuous infusion of opioid derived from the previous 24-hour PCA opioid requirement, and blood specimens were collected and stored for subsequent opioid analysis.
                Ten patients were enrolled in this study. Rapid escalation in opioid requirement commonly occurred at the commencement of PCA, followed by a variable plateau phase and then deescalation of opioid requirement after mucositis resolution. The measures demonstrated the safety and efficacy of the clinical protocol. In the concentrations used, there was no statistical difference between the mean daily pain, sedation, nausea and vomiting, and pruritus scores for both opioids (Friedman test). The analysis of variance of the log-total opioid doses per patient during periods 1, 2, and 3 indicated that patients used 27% more hydromorphone than expected from its presumed 7:1 ratio relative to morphine potency used in the PCA infusions. The mean plasma hydromorphone concentration was 4.7 ng/ml (range, 1.9 to 8.9 ng/ml), and the mean clearance was 51.7 ml/min per kilogram of body weight (range, 28.6 to 98.2 ml/min per kilogram). The mean plasma morphine, morphine-6-glucuronide, and morphine-3-glucuronide concentrations were 40.0 ng/ml (range, 15 to 62.5), 168.2 ng/ml (range, 54.4 to 231.9), and 391.0 ng/ml (range, 149.4 to 921.7), respectively. The mean morphine clearance was 34.3 ml/min per kilogram of body weight (range, 19.3 to 58.3). The mean molar ratios of morphine-6-glucuronide/morphine, morphine-3-glucoronide/morphine, and morphine-3-glucuronide/morphine-6-glucuronide were 2.48 (range, 1.4 to 3.3), 5.82 (range, 3.4 to 9.1), and 2.46 (range, 1.1 to 3.3), respectively.
                The safety and efficacy of a clinical protocol for the administration of opioids by means of PCA for mucositis pain after bone marrow transplantation was demonstrated. In this small study, hydromorphone was not superior to morphine in terms of analgesia or the side-effect profile: a larger study would be needed to show a difference. The clearances of hydromorphone and morphine in the children studied were generally greater than those previously recorded, but this finding may be related to disease or treatment variables. Apart from clearance, the morphine pharmacokinetics in the study population were similar to those previously recorded. Hydromorphone may be less potent in this population of children than indicated by adult equipotency tables. Many studies have shown the efficacy of patient-controlled analgesia (PCA). However, it is not clear whether PCA has clinical or economic benefits in addition to efficient analgesia. The current study was designed to evaluate these issues by comparing PCA with regularly administered intramuscular injections of opioids after hysterectomy.
                This prospective study included 126 patients who underwent abdominal hysterectomy and were randomly assigned to receive PCA or regularly timed intramuscular injections of morphine during a period of 48 h. Doses were adjusted to provide satisfactory analgesia in both treatment groups. Pain at rest and with movement, functional recovery, drug side effects, and patient satisfaction were measured using rating scales and questionnaires. The costs of PCA and intramuscular therapy were calculated based on personnel time and drug and material requirements.
                Comparable analgesia was observed with the two treatment methods, with no significant differences in the incidence of side effects or patient satisfaction. The medication dosage had to be adjusted significantly more frequently in the intramuscular group than in the PCA patients. The PCA did not favor a faster recuperation time compared with intramuscular therapy in terms of times to ambulation, resumption of liquid and solid diet, passage of bowel gas, or hospital discharge. The results of the economic evaluation, which used a cost-minimization model and sensitivity analyses, showed that PCA was more costly than regular intramuscular injections despite the fact that no costs for the pump were included in the analyses. Cost differences in nursing time favoring PCA were offset by drug and material costs associated with this type of treatment.
                Compared with regularly scheduled intramuscular dosing, PCA is more costly and does not have clinical advantages for pain management after hysterectomy. Because of the comparable outcomes, the general use of PCA in similar patients should be questioned. In the current study, 55 patients undergoing elective cholecystectomy were randomly allocated to receive postoperative analgesia (morphine sulfate) administered through either patient-controlled intravenous (PCA) or standard intramuscular (IM) routes. There were no significant differences in length of hospitalization or required dose of morphine sulfate. Patients randomized to PCA reported significantly improved subjective relief from pain and a smaller percentage of time in pain during each of the first two postoperative days. In addition, they reported less sedation and less interference with both postoperative breathing and pulmonary recovery than patients who received IM morphine. Theoretically, PCA regimens can deliver narcotic analgesia at a higher and more varied rate (with fewer side effects) compared with standard IM narcotic delivery, which is more limited by considerations of clinical doses. In PCA dosing, patients should experience less time in pain and sedation. The results of the current study support this premise. BACKGROUND AND THE PURPOSE OF THE STUDY: Oral mucositis is one of the most common complications of malignancy chemotherapy. As yet, no absolute treatment has been demonstrated to be effective for chemotherapy-induced oral mucositis. This study evaluates the effectiveness of phenytoin mouthwash as a wound healing agent, on the basis of stimulating effects on fibroblast proliferation.
                In this multicenter, randomized, placebo-controlled clinical trial; twelve patients received phenytoin mouthwash (0.5%) or placebo for about two weeks. Oral pain severity was scored on the daily basis using a VAS (visual analogue scale) of 10 centimeters. National Cancer Institute (NCI) scale was used to grade the intensity of mucositis. To determine the effect of treatment, a quality of life questionnaire, consisting of 35 queries, was filled out for all patients. Statistical analyses of data was performed using Mann-Whitney test.
                The average time for complete remission of mucositis in phenytoin-treated group was less than that of the placebo group. The quality of life improved dramatically in the phenytoin group with the healing process being more evident in the first week. Furthermore, reduction in the wound area was greater in the phenytoin group than controls at the end of the first week of treatment. Both groups eventually demonstrated reduction in pain intensity; however no statistically significant difference was observed between two groups.
                Phenytoin mouthwash accelerated wound healing and resolution of mucositis and improved life quality impressively. Thirty-six patients undergoing lower abdominal surgery were included in a prospective randomized controlled study to compare the effects of patient-controlled analgesia (PCA) and a standard intramuscular/intravenous treatment (conventional analgesia, CA) of postoperative pain. Morphine was used in both groups. There were no significant differences between the two analgesic regimens in respect of linear analogue pain scores, verbal pain-relief scores, amount of morphine used or side-effects. No treatment-induced alterations in vital values were experienced. Patient-controlled analgesia (PCA) with intravenous pethidine was compared with nurse-controlled pethidine infusions for pain relief in 200 patients after major abdominal or thoracic surgery. Pain, level of sedation, nausea and presence of other adverse effects, in addition to cumulative pethidine requirement, were measured for the first 24 hours after surgery. Both groups were similar for age, weight and type of surgery. There was no significant difference between the quality of analgesia achieved in both groups. The frequency and severity of adverse effects was also similar. The cumulative pethidine dose administered to both groups was identical. It is concluded that nurse-controlled opioid infusions are as effective as PCA and may be used as an alternative to PCA where this is either unavailable or unsuitable. Venous leg ulcers (ulcera crurum venosa) are frequently seen in elderly patients. It has been suggested that low level laser irradiation has a biostimulative and wound healing effect; however, this has not yet been clinically verified by controlled studies.
                The difference in size reduction of leg ulcers with and without low level laser or placebo laser treatment was measured in 44 patients randomised into two treatment groups (685-nm low level laser and placebo laser) or a control group which served to quantify the effect of laser application. All patients received standardized wound care.
                The aim of the study was to compare the effectiveness of low level laser irradiation with that of a placebo "light source". The size of the ulcers was planimetrically measured at baseline (day 1), at the end of therapy (day 28) and 2 months later (day 90). The difference in wound size was evaluated.
                There were no statistically significant differences in reduction of wound size between the three groups, thus suggesting that low level laser light does not have any stimulatory effect on wound healing in ulcera crurum venosa. Patient-controlled i.v. administration and intramuscular administration of morphine sulfate were compared in a crossover study to determine their relative effectiveness in relieving postoperative pain. Twenty adult patients scheduled for abdominal surgery were randomly assigned to one of two groups; one group received i.v. morphine sulfate for 24 hours using a patient-controlled analgesia (PCA) device, after which they were given morphine sulfate i.m. for 24 hours. The treatment order was reversed for the other group. Amount of narcotic administered, respiratory rate, and levels of discomfort, activity, and sedation were assessed by the nursing staff every two hours. At the end of each 24-hour treatment phase, patients ranked their level of pain, amount of pain relief, level of sedation, ability to sleep, and ability to perform pulmonary toilet. Patients were also asked whether they preferred PCA or i.m. analgesic therapy for future surgery. Patients reported significantly less discomfort while using PCA than during i.m. morphine administration. No significant differences in amount of narcotic used, respiratory rate, nausea and vomiting, or levels of activity or sedation were noted for the two regimens. Patients' rankings of the two treatment modes did not differ significantly, but a majority of patients indicated a preference for future use of PCA. In these postoperative patients, administration of i.v. morphine sulfate by PCA was as safe as i.m. administration and possibly more effective in relieving pain. Use of the low-energy helium-neon laser (LEL) appears to be a simple atraumatic technique for the prevention and treatment of mucositis of various origins. Preliminary findings, and significant results obtained for chemotherapy-induced mucositis in a previous phase III study, prompted a randomized multicenter double-blind trial to evaluate LEL in the prevention of acute radiation-induced stomatitis. Irradiation by LEL corresponds to local application of a high-photon-density monochromatic light source. Activation of epithelial healing for LEL-treated surfaces, the most commonly recognized effect, has been confirmed by numerous in vitro studies. The mechanism of action at a molecular and enzymatic level is presently being studied. From September 1994 to March 1998, 30 patients were randomized. Technical specification: 60 mW (25 mW at Reims, 1 patient), He-Ne, wavelength 632.8 nm. The trial was open to patients with carcinoma of the oropharynx, hypopharynx and oral cavity, treated by radiotherapy alone (65 Gy at a rate of 2 Gy/fraction, 5 fractions per week) without prior surgery or concomitant chemotherapy. The malignant tumor had to be located outside the tested laser application areas (9 points): posterior third of the internal surfaces of the cheeks, soft palate and anterior tonsillar pillars. Patients were randomized to LEL or placebo light treatment, starting on the first day of radiotherapy and before each session. The treatment time (t) for each application point was given by the equation : t(s)= energy (J/cm2) x surface (cm2)/Power (W). Objective assessment of the degree of mucositis was recorded weekly by a physician blinded to the type of treatment, using the WHO scale for grading of mucositis and a segmented visual analogue scale for pain evaluation. Protocol feasibility and compliance were excellent. Grade 3 mucositis occured with a frequency of 35.2% without LEL and of 7.6% with LEL (P<0.01). The frequency of "severe pain" (grade 3) was 23.8% without LEL, falling to 1.9% with LEL (P<0.05). Pain relief was significantly reduced throughout the treatment period (weeks 2-7). LEL therapy is capable of reducing the severity and duration of oral mucositis associated with radiation therapy. In addition, there is a tremendous potential for using LEL in combined treatment protocols utilizing concomitant chemotherapy and radiotherapy. To evaluate the effect of dexamethasone, diclofenac, and a placebo given for 3 weeks after phacoemulsification and intraocular lens (IOL) implantation on the formation of posterior capsule opacification (PCO).
                St. Erik's Eye Hospital, Stockholm, Sweden.
                In a 2-year prospective randomized double-blind study, a laser flare meter was used to measure aqueous flare intensity preoperatively and 3 days, 2 weeks, and 2 years after phacoemulsification and IOL implantation. Posterior capsule opacification was evaluated 2 years postoperatively using retroillumination images taken with a Scheimpflug camera. The Evaluation of Posterior Capsule Opacification system was used to score the areas of PCO density.
                The median rate of PCO 2 years after phacoemulsification was 0.72 (range 0.32 to 1.57) in the dexamethasone group, 0.78 (range 0.19 to 2.14) in the diclofenac group, and 0.70 (range 0.35 to 1.70) in the placebo group. The differences were not statistically significant (P>.05; Kruskal-Wallis analysis of variance, multiple comparisons). The rate of neodymium:YAG laser posterior capsulotomy during the 2 years after surgery was not statistically different between groups (P>.05, chi-square test). There was no correlation (Spearman rank coefficient) between laser flare measurements and PCO formation in any group during the study (P>.05).
                Topical instillation of diclofenac, dexamethasone, or a placebo in the immediate period after phacoemulsification and IOL implantation did not seem to influence the formation of PCO 2 years after cataract surgery. Acute mucositis is dose-limiting in many accelerated radiotherapy schedules for head and neck cancer. Cytokines may be one means of reducing the severity of mucositis. A study was designed to assess the effect of subcutaneous molgramostin (granulocyte-macrophage colony stimulating factor; GM-CSF) injections on acute radiation morbidity in patients undergoing accelerated radiotherapy for laryngeal cancer. A prospective, randomized, observer-blind, controlled trial was conducted in 29 patients who were to receive radical radiotherapy over 3 weeks for early stage laryngeal cancer. Patients were randomized to receive 150 microg (approximately 2 microg kg(-1)) GM-CSF subcutaneously once daily for 14 days after the second week of radiotherapy, or no GM-CSF. Patients were assessed weekly for grade of mucositis, skin reactions and related parameters. The severity of mucositis was reduced in the GM-CSF arm (p<0.05). No other end-points reached statistical significance. Two patients failed to complete their courses of GM-CSF. Three developed influenza type symptoms and in one an allergic reaction was noted. There was no difference in tumour control rates. Subcutaneous GM-CSF reduced the severity of mucositis in patients undergoing accelerated radiotherapy. Injections were well tolerated. Further studies of cytokines are warranted, to assess the feasibility of increasing the total doses of accelerated radiotherapy given, with the aim of improving tumour cure rates. Postoperative nausea and vomiting (PONV) are frequent side effects of general anesthesia in children. The aim of this study was to compare the effectiveness of laser acupuncture with metoclopramide in prevention of PONV in children after sevoflurane anesthesia.
                A total of 120 children ASA I and II, scheduled for hernia repair, circumcision or orchidopexy were randomly assigned into three groups: group I, received laser acupuncture on P6 point and saline infusion; group II, metoclopramide 0.1 mg.kg(-1) i.v. and sham laser; group III had sham laser and saline infusion. Anesthesia was maintained with sevoflurane and N(2)O/O(2). Patients were monitored for any symptoms of retching and vomiting at 2, 6 and 24 h postoperatively.
                The incidence of vomiting was higher in the control group in the first 2 h postoperatively (P < 0.001), compared with the other groups. There was no statistically significant difference between acupuncture and metoclopramide groups in occurrence and timing of vomiting (P < 0.001).
                Laser acupuncture is equally effective as metoclopramide in preventing PONV in children.
There is limited evidence from two small trials that low level laser treatment reduces the severity of the mucositis. Less opiate is used for PCA versus continuous infusion. Further, well designed, placebo or no treatment controlled trials assessing the effectiveness of interventions investigated in this review and new interventions for treating mucositis are needed.