May 06, 2010
Controlled-Release Ibuprofen Safe, Effective, for Moderate-to-Severe Pain Following Oral SurgeryBALTIMORE, Md.—Patients who received controlled-release ibuprofen following removal of impacted third molars attained significantly better pain relief at every efficacy parameter assessed versus placebo, researchers concluded.
Steven Christensen, DDS, of Jean Brown Research, Salt Lake City, Utah, and colleagues conducted a double-blind, repeat-dose parallel study in which 161 patients received the oral investigational controlled-release ibuprofen 600 mg (approximately 200 mg released immediately followed by a sustained release of 400 mg) and 83 received placebo every 12 hours for a total of four doses over 48 hours. Co-primary end points were efficacy for 8-12 hours following dose 1 and proportion of patients with meaningful pain reduction at 24, 36, and 48 hours. During the 48-hour observation period, pain intensity and relief were evaluated using categorical scales. Two stopwatches—one assessing “first perceptible” relief and the other “meaningful” relief—recorded results during the initial 12-hour dosing period. Use of rescue medication was also recorded. Patients provided a global evaluation of their pain at 12 hours or at dose 2, or at rescue medication if it occurred prior to hour 12.
Mean age of the patients was 18.9 years in the controlled-release ibuprofen group and 18.8 years in the placebo group; 56% of those receiving controlled-release ibuprofen were female vs 54% of the placebo group. The majority of the patients were Caucasian. Prior to the first dose, 44% of patients (n=75) in the controlled-release ibuprofen group had pain intensity ≤7, as did a similar number in the placebo group (45%; n=39).
In the group randomized to receive controlled-release ibuprofen, 69.2% reported “meaningful” relief compared with 17.2% in the placebo group. Similarly, 71.6% had “first perceptible” relief within the first hour with controlled-release ibuprofen vs 33.3% for placebo. Both end points were statistically significant (P<0.0001).
Median duration of analgesia was 720 minutes after dose 1 for the controlled-release ibuprofen group and 101 minutes for the placebo group. Over the 48-hour study, at least one dose of rescue medication was required by 41.4% of patients receiving controlled-release ibuprofen and 85.1% of the placebo group. One subject in the controlled-release ibuprofen group had mild Stevens-Johnson syndrome 7 days after the last dose of study drug, which resolved after 11 days. No serious adverse events were reported for either group.
In this patient population treated for postoperative oral surgery pain, controlled-release ibuprofen has a reasonable onset of action and a prolonged duration of effect, the investigators reported during the American Pain Society's 29th Annual Scientific Meeting.