Clinical Trial of Combination of Acetaminophen, Ibuprofen and Caffeine on Pain Relief and Analgesic Use After Impacted Lower Third Molar Surgery

Objectives: Relieving a very painful procedure such as impacted lower third molar surgery by combining analgesics into a single product using their synergistic effects is favorable. We designed a prospective, randomized, double-blind clinical trial to study the beneficial effect of the combination of acetaminophen, ibuprofen, and caffeine on reducing the severity of postoperative pain after impacted lower third molars surgery. Methods: This was a double-blinded clinical trial on 108 patients scheduled for impacted third molar surgery. The patients were randomly assigned into 2 groups. Two hours before the procedure the intervention group received combination therapy of acetaminophen (600 mg), ibuprofen (400 mg), and caffeine (15 mg) as pre-emptive analgesia, and the control group received placebo. All patients received gelofen capsules (400 mg) uniformly after the intervention as PRN. Postoperative assessment of pain severity using a 10-point visual analog scale (VAS) and analgesic consumption was performed at 2, 4, 6, and 8 hours after the operation. All statistical analyses were performed using SPSS software (version 19.0, SPSS Inc., Chicago, Illinois), with chi-square test or Fisher’s and Mann-Whitney U test. Results: The severity of preoperative pain did not differ before receiving the first dose of study drugs. However, at any time points after the surgery, the mean pain score was significantly lower in the group who received combination regimen than the control group (P < 0.001). In a general linear model, using a repeated-measures analysis, concerning the analgesic dose administered after the surgery, the mean number of doses in 8 hours was 0.96 for the combination therapy group and 1.8 for the control group, with a significant difference (P = 0.022). Conclusions: The pre-emptive combination therapy including acetaminophen, ibuprofen, and caffeine can be used efficiently to control postoperative pain after impacted third molar surgery. © 2017, Shiraz University of Medical Sciences.