A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-controlled, factorial study

Clinical Therapeutics
Donald R MehlischKyle S Christensen

Abstract

The combination of ibuprofen and paracetamol may confer analgesic benefits over monotherapy with either agent. In a previous study, an ibuprofen/paracetamol combination provided significantly better analgesic efficacy than comparable doses of ibuprofen or paracetamol alone in patients experiencing moderate to severe acute postoperative pain after extraction of impacted third molars. This study compared the efficacy and tolerability of 3 doses of a single-tablet fixed-dose combination (FDC) of ibuprofen and paracetamol (ibuprofen/paracetamol doses of 100 mg/250 mg, 200 mg/500 mg, and 400 mg/1000 mg) with comparable doses of ibuprofen (200 or 400 mg) monotherapy, paracetamol (500 or 1000 mg) monotherapy, and placebo in the 8 hours after surgical removal of 3 to 4 impacted third molars (stage 1) and with placebo over the next 72 hours (stage 2). This was a multicenter, 2-stage, randomized, double-blind, parallel-group, placebo-controlled, factorial study. Male or female outpatients were eligible for the study if they were aged >or=16 years, were referred for surgical removal of at least 3 impacted third molars (2 of which had to be mandibular impacted molars), and gave written informed consent. In stage 1, patients were randomly a...Continue Reading

References

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Citations

Sep 16, 2011·Current Medical Research and Opinion·Charles Argoff
Jul 5, 2011·Paediatric Anaesthesia·Jacqueline Hannam, Brian J Anderson
Jun 25, 2013·The Cochrane Database of Systematic Reviews·Christopher J DerryR Andrew Moore
Dec 14, 2012·The Cochrane Database of Systematic Reviews·Blánaid DalyHelen V Worthington
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Dec 18, 2013·The Cochrane Database of Systematic Reviews·Edmund BaileyZahid Afzal
Jan 15, 2014·The Cochrane Database of Systematic Reviews·Rebecca NormansellParameswaran Nair
Jun 26, 2020·Acta Paediatrica·Tove KamsvågGustaf Ljungman
Jul 4, 2015·British Journal of Clinical Pharmacology·Konrad Heintze, Winfried Fuchs
Sep 10, 2017·British Journal of Clinical Pharmacology·Sebastián VidelaCarlos Plata-Salamán

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