Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial

Abstract

Background: Acetaminophen is often used with a non-steriodal anti-inflammatory drug for acute pain. Hitherto, these drugs have had to be given separately, typically at different time intervals. Maxigesic tablets combine acetaminophen and ibuprofen in clinically appropriate doses to simplify administration and dosage regimen. We compared this combination with each of the constituent drugs for the relief of pain after extraction of third molar teeth.

Methods: Adults (more than 16 yr) having one or more wisdom teeth removed under general or local anaesthesia were instructed to take two tablets before operation, then two tablets every 6 h for up to 48 h of: (i) a combination of acetaminophen 500 mg and ibuprofen 150 mg per tablet (Maxigesic); (ii) acetaminophen 500 mg per tablet alone; or (iii) ibuprofen 150 mg per tablet alone. The primary outcome measure was the area under the curve (AUC) of the 100 mm visual analogue scale pain measurements taken for up to 48 h after surgery, divided by time, at rest and on activity. Pharmacokinetic data were collected in a subset of patients.

Results: The mean (sem) time-corrected AUC on rest and activity, respectively, were: combination group 22.3 (3.2) and 28.4 (3.4); acetaminophen group 33.0 (3.1) and 40.4 (3.3); and ibuprofen group 34.8 (3.2) and 40.2 (3.4); P<0.01 for each of the four comparisons of combination vs constituent drug. There was no pharmacokinetic interaction between acetaminophen and ibuprofen administered together.

Conclusions: Maxigesic tablets provide superior pain relief after oral surgery to acetaminophen or ibuprofen alone.

Fig 1

Flow of participants through trial. Not randomized (n=54): (i) declined to participate (n=15), (ii) did not meet inclusion criteria (n=14), (iii) other reasons (n=25); other reasons: the surgery was cancelled or rescheduled; patient could not be contacted; patient was given the wrong date of the surgery.

Fig 2

Mean (+95% CI) mm of time-adjusted AUC (AUC/time) for VAS at rest and on activity by treatment group.

Fig 3

Mean (se) mm VAS out of 100 at rest (a) and on activity (b).