Attenuation of emetic side effects of patient-controlled analgesia.
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BACKGROUND: Successful management of postoperative pain requires that adequate analgesia is achieved without excessive adverse effects. Opioid-induced nausea and vomiting is known to impair patients' satisfaction, but there are no studies providing sufficient power to test the hypothesis that the incidence of opioid-induced nausea and vomiting differs between micro -opioid receptor agonists. Thus, we tested the hypothesis that the incidence of vomiting and nausea differs between morphine and piritramide. METHODS: In a prospective, randomized, double-blind fashion, we administered either morphine (n=250) or piritramide (n=250) by patient-controlled analgesia (PCA) for postoperative pain relief. We used a bolus dose of 1.5 mg with a lockout time of 10 min. Incidence and intensity (numerical rating scale) of postoperative nausea, vomiting, pain, patient satisfaction (score 0-10), side-effects (score 0-3) and drug consumption were measured. RESULTS: Mean drug consumption did not differ between the piritramide and morphine groups (30.8 (SD 22.4) mg day(-1) vs 28.4 (21.8) mg day(-1)) during the first postoperative day and there were no significant differences in the overall incidence of nausea (30% vs 27%) and vomiting (19% vs 15%). Intensity of nausea correlated inversely (P=0.01) with morphine consumption but not with piritramide consumption. Pain scores both at rest (2.2 (1.9) vs 2.6 (2)) and during movement (4.4 (2.2) vs 4.9 (2.3)) were slightly but significantly less with morphine. CONCLUSIONS: Opioid-induced emesis was observed in about one-third of the patients using morphine and piritramide for PCA and the incidence of vomiting was one-half of that. Potential differences in the incidence of vomiting during PCA therapy between these micro-opioid receptor agonists can be excluded.
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BACKGROUND: This study was undertaken to compare the efficacy and tolerability of ondansetron plus dexamethasone (O + D) with metoclopramide plus dexamethasone plus lorazepam (M + D + L) over three consecutive courses of cisplatin chemotherapy. PATIENTS AND METHODS: This was an international, multicentre, double-blind, double-dummy, parallel group study. O+D patients were randomised to receive ondansetron 8 mg intravenously (i.v.) plus dexamethasone 20 mg i.v. prior to cisplatin (50-100 mg/m2) chemotherapy. On the following 4 days they were treated with ondansetron 8 mg bd orally and dexamethasone 4 mg bd orally. M + D + L patients were randomised to receive metoclopramide 3 mg/kg i.v., dexamethasone 20 mg i.v. and lorazepam 1.5 mg/m2 i.v. (max 3 mg) prior to cisplatin chemotherapy and a further dose of metoclopramide 3 mg/kg i.v. approximately 2 hours following the first dose of metoclopramide. Treatment for the following 4 days was metoclopramide 40 mg tds and dexamethasone 4 mg bd orally. Two hundred and thirty-seven patients were recruited into the study (117 patients received O + D and 120 received M + D + L). RESULTS: On the first course chemotherapy, O + D was significantly superior to the M + D + L regimen for complete control of emesis (days 1-5, 54% versus 37%, respectively, P = 0.014). This was maintained over the three treatment cycles; 38% of O + D and 20% of M + D + L patients remained free of emesis (P = 0.003). Maintenance of control of nausea grade as none or mild on days 1-5 over the three courses was significantly better in the O + D group (48%) than in the M + D + L (26%, P = 0.003). The most commonly occurring adverse events in the O + D group were constipation (25%) and headache (19%). In the M + D + L group drowsiness (38% of patients), malaise/fatigue (16% of patients), constipation (13% of patients), anxiety (11% of patients) and dizziness (10% of patients) were the most commonly reported adverse events. Extrapyramidal symptoms were reported by 20% of patients in the M + D + L group. Despite the inclusion of lorazepam, 14% of patients in the M + D + L group were withdrawn from the study due to extrapyramidal symptoms, which in the opinion of the investigators, were probably or almost certainly related to study medication. CONCLUSION: This study show that O + D is significantly more effective and better tolerated than M + D + L for the control of emesis and nausea over a series of three courses of cisplatin chemotherapy.
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OBJECTIVE: To assess the effects of unilateral or bilateral otoplasty on bradycardia and postoperative nausea and vomiting (PONV) and the efficiency of transdermal scopolamine in the prophylaxis of PONV. STUDY DESIGN: Post hoc assessment of the data from a double-blind, randomized study. METHODS: Fifty otoplasty patients were studied; half of them received randomly and in double-blind fashion a transdermal therapeutic system (patch) of scopolamine (TTS-scopolamine) as prophylaxis against PONV before general anesthesia. The placebo group received atropine 10 microg x kg(-1) intravenously during induction. RESULTS: The scopolamine-treated patients suffered more from moderate peroperative bradycardia (8/25; P < .05) than the atropine-treated patients (1/25). Two patients wearing a half of the TTS-scopolamine patch needed intravenous atropine. After unilateral otoplasty, none of the TTS-scopolamine-treated patients and 50% of the atropine-treated patients suffered from PONV. After bilateral operation, the respective incidences were 39% and 81% (P < .01). After unilateral otoplasty no patient needed droperidol, but after bilateral otoplasty, 12 of 19 of the atropine-treated and 4 of 18 (P < .05) of the scopolamine-treated patients needed droperidol. The mean numbers of doses of droperidol were 0.8+/-0.9 and 0.3+/-0.6 (P < .05), respectively. Two additional patients, wearing half of the TTS-scopolamine patch, suffered from mild central anticholinergic syndrome. CONCLUSION: TTS-scopolamine offers effective prophylaxis against PONV (auriculoemetic reflex), but does not protect from bradycardia (auriculocardiac reflex) in otoplasty. Cutting of the TTS-scopolamine patch may lead to undesirable side effects.
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