Clinical pharmacology and therapeutics
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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.
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Clin. Pharmacol. Ther. · Nov 1992
Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer.
The single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone have been determined in patients with moderate to severe cancer pain. The mean +/- SD elimination half-life after single-dose administration of intravenous (4.6 mg to 9.1 mg) and oral (9.1 mg) oxycodone was 3.01 +/- 1.37 hours and 3.51 +/- 1.43 hours, respectively. After intravenous administration, the mean +/- SD volume of distribution was 211.9 +/- 186.6 L, and the mean +/- SD total plasma clearance was 48.6 +/- 26.5 L/hr. ⋯ Intravenous oxycodone produced a faster onset of pain relief than oxycodone tablets, but the duration of analgesia was approximately the same (4 hours). However, the incidence of side effects and their severity were significantly higher (p < 0.05) for intravenous oxycodone than for oxycodone tablets. The marked interindividual variation observed in the pharmacokinetics and pharmacodynamics of oxycodone in this study supports the need for individualized dosing regimens.
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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.
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Clin. Pharmacol. Ther. · Oct 1992
Pharmacokinetics and pharmacodynamics of intravenous meperidine in neonates and infants.
The pharmacokinetics of meperidine (pethidine) was studied in 21 infants who received a single intravenous dose of 1 mg/kg after surgery (n = 18) or during mechanical ventilation because of respiratory distress (n = 3). Eleven patients were younger than 1 week old, 10 patients were aged from 3 weeks to 5 months, and five of the patients were premature. ⋯ The great interindividual variability in meperidine pharmacokinetics should be taken into consideration when meperidine is administered to neonates. Although no life-threatening or serious side effects were observed in this study, appropriate care should be exercised when prescribing meperidine for this age group.