International journal of clinical pharmacology research
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Int J Clin Pharmacol Res · Jan 2001
Randomized Controlled Trial Multicenter Study Clinical TrialShort-term treatment of primary fibromyalgia with the 5-HT3-receptor antagonist tropisetron. Results of a randomized, double-blind, placebo-controlled multicenter trial in 418 patients.
We investigated the efficacy and tolerability of short-term treatment with tropisetron, a selective, competitive 5-HT3-receptor antagonist in fibromyalgia. The trial was designed as a prospective, multicenter, double-blind, parallel-group, dose-finding study. We randomly assigned 418 patients suffering from primary fibromyalgia to receive either placebo, 5 mg, 10 mg or 15 mg tropisetron once daily for 10 days. ⋯ The safety and tolerability of tropisetron was good; gastrointestinal tract symptoms were the most frequently reported adverse events. Short-term treatment of fibromyalgia patients with 5 mg tropisetron for 10 days proved to be efficacious and well tolerated. In this study a bell-shaped dose-response curve was seen.
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Int J Clin Pharmacol Res · Jan 1999
Randomized Controlled Trial Comparative Study Clinical TrialAnalgesic effects of diclofenac suppository and injection after preoperative administration.
Diclofenac sodium (100 mg) has been introduced in the Caribbean as a suppository formulation. In a randomized single-blind (observer-blind) clinical trial, the postoperative analgesic efficacy of diclofenac administered either as a conventional intramuscular injection (75 mg) or as the available suppository formulation (100 mg) was studied in 44 adult male patients undergoing herniorrhaphy in same day surgery. Diclofenac was administered preoperatively at induction of anesthesia to patients (grades ASA I and II) after they had given informed consent. ⋯ The times for requests for additional analgesia and the number of patients requesting further analgesia did not differ. Patients who received the suppository were discharged earlier than those who received the injection (40 min vs. 65 min p = 0.02). This preliminary study of the two marketed formulations of diclofenac demonstrated that both preparations provided equivalent analgesia but patients who received the suppository preparation were discharged earlier.
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Int J Clin Pharmacol Res · Jan 1998
Randomized Controlled Trial Clinical TrialTramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo.
This study assessed the analgesic action of tramadol compared with placebo in patients suffering from fibromyalgia syndrome. Twelve patients (11 females, one male) were treated according to a double-blind crossover experimental design. Each patient, after signing informed consent, was randomly allocated to either tramadol (100 mg ampul in 100 ml given intravenously in 15 min doses) or placebo for a single dose treatment. ⋯ During the first treatment cycle effective control of spontaneous pain was achieved with tramadol, which determined a reduction of 20.6% while with the placebo spontaneous pain increased by 19.8%. With pressure dolorimetry there were no clinically important differences observed after either active treatment or placebo. The contrasting results found in the present study could be a stimulus for the organization of new projects, which may lead to the identification of an optimal therapeutic approach for fibromyalgic patients, also using tramadol for long periods.
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Int J Clin Pharmacol Res · Jan 1998
Randomized Controlled Trial Clinical TrialAnalgesic activity of tramadol and pentazocine in postoperative pain.
This controlled, completely randomized trial was designed to compare the efficacy and safety of tramadol and pentazocine in the treatment of postoperative pain. A total of 50 adults were admitted (31 males, 19 females, mean age 48 years) to undergo hemorrhoidectomy or traumatological or abdominal surgery. Following a randomization list, each patient was given one ampul of tramadol (100 mg/2 mL) or pentazocine (30 mg/mL) by intramuscular injection at 8-h intervals for 3 days. ⋯ Final judgments on efficacy and acceptability were in favor of tramadol (p < 0.01 from pentazocine). Local and systemic safety were good, with no reactions at the injection site and no changes in vital parameters or laboratory findings. No patient reported any adverse reactions.
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Int J Clin Pharmacol Res · Jan 1998
Randomized Controlled Trial Clinical TrialThe impact of the menstrual cycle and ondansetron on postoperative nausea and vomiting.
The incidence of postoperative nausea and vomiting was studied in a prospective group of 94 women of child-bearing age (18-42 years), undergoing unilateral elective thyroid surgery. In a subgroup of 47 examinees the postoperative nausea and vomiting episodes were analyzed according to the time of surgery within their menstrual cycle: the highest occurrence was observed in the periovulatory and premenstrual periods (65.5% vs. 27.8%, p < 0.02). ⋯ It is concluded that elective surgery in young and middle-aged female patients is best avoided premenstrually and in the middle of their cycle. In these very periods, however, ondansetron effectively reduces the incidence and intensity of postoperative nausea and vomiting by about 70%.