A double-blind placebo-controlled comparison of three ibuprofen/codeine combinations and aspirin.

In a double-blind, single dose study of analgesic efficacy, 165 patients who were expected to develop moderate to severe pain following the removal of an impacted mandibular third molar tooth were allocated to receive aspirin, placebo, or an increasing dose of a fixed ratio ibuprofen/codeine combination. The degree of pain experienced prior to medication was noted and the patients were asked to record the degree of pain and of pain relief hourly for the following 5 hours. The study produced clear evidence of the superior efficacy of the combinations when compared to placebo and aspirin. In addition, the high dose combination appeared to be superior with respect to pain relief and the need for additional analgesia compared to the low dose treatment. There were few side effects and only one severe reaction was reported by a patient in the high dose group. To avoid side effects it is suggested that the medium-dose combination, ibuprofen 400 mg/codeine 30 mg, is optimal.

RCT Entities:   Population Interventions Outcomes