Evaluation of an ibuprofen controlled-release tablet and placebo in postoperative oral surgery pain.

Seventy-four outpatients with postoperative pain after oral surgery were randomly assigned, on a double-blind basis, to receive a single oral dose of a controlled-release tablet (CRT) containing 600 mg ibuprofen, two 600-mg ibuprofen CRTs, or placebo. Using a self-rating record, subjects rated their pain and its relief hourly for 12 hours after medicating. Estimates of total and peak analgesia were derived from these subjective reports. The ibuprofen CRTs (600 and 1200 mg) had manifested an analgesic effect by hour 1 and their efficacy persisted for 12 hours. Comparable effect for the two ibuprofen CRT dosages could suggest a plateau in analgesia at the 600-mg level or a lack of upside assay sensitivity. Duration of effect was longer for the CRTs than we have previously observed with conventional ibuprofen tablets. Adverse effects were transitory and consistent with the known pharmacologic profile of the medication evaluated.