Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · Dec 1988
Randomized Controlled Trial Comparative Study Clinical TrialSore throat pain in the evaluation of mild analgesics.
A double-blind, single-dose parallel study was conducted to assess refinements of a previously tested model for evaluating treatment of sore throat pain. Patients with tonsillopharyngitis randomly received either 400 mg ibuprofen (n = 39), 1000 mg acetaminophen (n = 40), or placebo (n = 41). At hourly intervals for 6 hours the patients reported pain intensity and pain relief on conventional scales and two sensory qualities of throat pain ("swollen throat" and "difficulty swallowing") on two new visual analog scales. ⋯ Ibuprofen, 400 mg, was more effective than acetaminophen, 1000 mg, on all rating scales, conventional and new, at all time points after 2 hours and overall (p less than 0.01). There were no side effects. We conclude that sore throat is a pain model that can be used to discriminate between active medication and placebo, as well as between two effective over-the-counter analgesics.
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Clin. Pharmacol. Ther. · Dec 1988
Randomized Controlled Trial Clinical TrialThe combination of ibuprofen and oxycodone/acetaminophen in the management of chronic cancer pain.
Thirty subjects with chronic moderate to severe pain who were receiving oxycodone/acetaminophen (oxy/APAP) for analgesia were initially evaluated for at least 7 days for oxy/APAP requirements for pain control. Each subject then received, in a randomized double-blind fashion, either 600 mg ibuprofen or placebo for an additional 7 days while hospitalized. Oxy/APAP usage was recorded daily along with efficacy and toxicity parameters. ⋯ Overall global scores showed a marked preference for the ibuprofen combination over placebo (p less than 0.01). Daily pain intensity (p less than 0.05) and pain relief scores (p less than 0.05) also improved with the addition of ibuprofen. This study indicates that ibuprofen is efficacious in the management of chronic cancer pain, resulting in both enhanced analgesia and a reduction in concomitant narcotic use.
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Preliminary data have suggested that phenytoin systemic clearance may increase during initial therapy in critically ill patients. The objectives for this study were to model the time-variant phenytoin clearance and evaluate concomitant changes in protein binding and urinary metabolite elimination. Phenytoin was given as an intravenous loading dose of 15 mg/kg followed by an initial maintenance dose of 6 mg/kg/day in 10 adult critically ill trauma patients. ⋯ Phenytoin free fraction increased in a majority of patients during the study period, with a binding ratio inversely related to albumin. Measured urinary p-HPPH data were consistent with the proposed model. A loading and constant maintenance dose of phenytoin frequently yielded a substantial, clinically significant fall in plasma concentrations with a pattern of apparently increasing clearance that may be a consequence of changes in protein binding, induction of metabolism, or the influence of stress on hepatic metabolic capacity.