Clinical pharmacology and therapeutics
-
Clin. Pharmacol. Ther. · May 1993
Randomized Controlled Trial Clinical TrialA placebo-controlled model for assaying systemic analgesics in children.
To assess the sore throat pain model in children as an assay for systemic analgesic agents in children under double-blind, placebo-controlled conditions, we conducted a single-dose parallel study that compared 10 mg/kg ibuprofen (n = 39), a new analgesic agent for children, and 15 mg/kg acetaminophen (n = 38), an approved analgesic for children, to placebo (n = 39) in children from 2 to 12 years of age with acute sore throat. At 1/2, 1, 2, 3, 4, 5, and 6 hours (2 hours in the pediatrician's office followed by 4 hours at home), children assessed pain intensity with a pain thermometer and pain relief with a smiley-face scale. The parent and pediatrician assessed pain intensity and change in pain; the parent also provided an overall evaluation at 6 hours. ⋯ Both active agents significantly (p < 0.05) reduced oral temperature in children with baseline temperatures > 99 degrees F. No treatment-related adverse effects were observed. We conclude that the sore throat pain model is a sensitive assay for identification of the activity of oral analgesic drugs in children and that ibuprofen is an effective analgesic in children.
-
Clin. Pharmacol. Ther. · Oct 1992
Randomized Controlled Trial Comparative Study Clinical TrialComparison of intravenous ketorolac with morphine for postoperative pain in children.
Ninety-two children from 3 to 12 years of age were given intravenous morphine or ketorolac by titration, or ketorolac by bolus injection for moderate or severe postsurgical pain in a double-blind randomized parallel-group study. Pain scores were assessed every 5 minutes until pain relief was complete, and then every 15 minutes for 8 hours or until pain returned. Twenty-nine of 30 patients receiving morphine and 25 of 30 patients in each group receiving ketorolac achieved pain relief. ⋯ Median durations of analgesia from initial drug administration were 170, 190, and 225 minutes in the morphine, ketorolac titration, and ketorolac bolus groups, respectively. The most common side effect was injection site pain. Analgesia after intravenous ketorolac developed more slowly but was sustained better than morphine.
-
Clin. Pharmacol. Ther. · Aug 1992
Randomized Controlled Trial Comparative Study Clinical TrialA new method for rate of analgesic onset: two doses of intravenous morphine compared with placebo.
A new method of frequent early pain assessments for 1 hour only was used to determine time of onset of analgesia after intravenous administration of 10 mg morphine, 5 mg morphine, or placebo in a double-blind study; 79 patients were randomized if they required parenteral analgesia in the early postoperative period. Pain intensity was determined by a four-point categoric verbal rating scale and on a verbal ordinal scale from 0 to 100 (0 = no pain, 100 = worst pain imaginable) during the first hour after analgesic administration. The onset time of analgesia, assessed by 50% of patients achieving 25% reduction from their baseline pain assessment, was significantly faster for 10 mg morphine compared with 5 mg morphine (p = 0.02) and placebo (p less than 0.01). More familiar analgesic efficacy measures, including the sum of pain intensity differences and time to next analgesic dose, similarly showed the superiority of 10 mg morphine to placebo in the first hour, confirming sensitivity according to the conventional paradigm.
-
Clin. Pharmacol. Ther. · Jul 1992
Randomized Controlled Trial Multicenter Study Clinical TrialOndansetron is effective in decreasing postoperative nausea and vomiting.
The efficacy of ondansetron, a selective 5-HT3 receptor antagonist, in preventing postoperative nausea and vomiting in surgical patients was studied. Fifty women were randomized in a double-blind manner to receive either two 8 mg doses of intravenous ondansetron or two doses of placebo vehicle: the first given just before general anesthesia induction and the second 8 hours later. During the first 24 postoperative hours, the number of emetic episodes was recorded and the subjects rated their nausea on a scale from 0 to 10. ⋯ The number of complete responders (no emetic episodes and no rescue therapy) was 1 of 24 (4%) and 15 of 26 (58%) in the placebo and ondansetron groups, respectively (p less than 0.001). Ondansetron is clearly more effective than placebo in the prophylaxis of postoperative nausea and vomiting. The adverse event profile for ondansetron was similar to that of placebo.
-
Clin. Pharmacol. Ther. · Jun 1992
Randomized Controlled Trial Comparative Study Clinical TrialAnalgesic oral efficacy of tramadol hydrochloride in postoperative pain.
Tramadol hydrochloride is a synthetic opiate agonist with a plasma elimination half-life of 5 to 6 hours and peak plasma levels at about 1 1/2 hours. It derives its activity from attachment to the mu-receptor and blockage of norepinephrine reuptake. The purpose of this single-dose, double-blind, placebo-controlled study was to determine the analgesic effectiveness of an oral administration of two dose levels of tramadol hydrochloride (75 or 150 mg) compared with the combination of 650 mg acetaminophen plus 100 mg propoxyphene napsylate in 161 patients with severe postoperative pain after cesarean section. ⋯ The 150 mg dose of tramadol was significantly more effective than the acetaminophen-propoxyphene combination from hour 2 through hour 6 for the sum of pain intensity differences and total pain relief scores, as well as for the global rating of the medication. Tramadol hydrochloride at both dose levels is an effective analgesic agent and at 150 mg is statistically superior to the acetaminophen-propoxyphene combination. No serious adverse effects were observed; however, dizziness was more frequently reported with 150 mg tramadol.