COMPARATIVE ANALGESIC EFFECTS OF SINGLE-DOSE PREOPERATIVE ADMINISTRATION OF PARACETAMOL (ACETAMINOPHEN) 500 mg PLUS CODEINE 30 mg AND IBUPROFEN 400 mg ON PAIN AFTER THIRD MOLAR SURGERY.

ABSTRACT

BACKGROUND: Efficacy and rapid onset of postsurgical oral pain relief are critical to improve clinical outcomes and reduce the risk of excessive dosing with analgesic drugs. PURPOSE: To compare analgesic effects of preoperative administration of paracetamol 500 mg plus codeine 30 mg in single-tablet and effervescent formulation to ibuprofen 400 mg, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery. MATERIALS AND METHODS: One hundred twenty healthy outpatients aged 15-29 years undergoing surgical removal of 1 bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group APAP/COD), ibuprofen 400 mg (group IBU) or placebo (group PLA). Rescue therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in groups APAP/COD and PLA and ibuprofen 400 mg in group IBU. Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications and time of the first intake, until 12-hours after surgery and over extra 2 days, RESULTS: Over postoperative 3 days, patients in the APAP/COD group (2.33 ± 1.99) displayed significantly (P< .001) less pain intensity than IBU (3.43 ± 2.47) and placebo (3.57 ± 2.62) groups. The first-day postoperative pain was significantly (P < .001) higher in group PLA than in groups APAP/COD and IBU, but not between the latter 2 groups. However, at 2 hours postdose, the IBU group displayed average pain intensity lower than APAP/COD group (P> .05). On the next 2 days, pain intensity was significantly (P< .001) lower in group APAP/COD than in groups IBU and PLA but failed to reach statistical significance between groups IBU and PLA. Although the time to the first using rescue therapy was longer (445.88 ± 159.96 minute) in group IBU, compared to groups APAP/COD (392.67 ± 138.90 minutes) and PLA (323.00 ± 143.95 minutes), the number of supplemented tablets was significantly higher in group IBU (2.89 ± 2.13) than in groups APAP/COD (1.24 ± 1.79) (P= .001) and PLA (1.53 ± 1.67) (P = .008). No adverse events were registered for all groups. CONCLUSIONS: Within the limits of the present study, over postoperative 3 days, a statistically significant intensity pain reduction and decreased rescue therapy consumption were recorded in the paracetamol-codeine group than to ibuprofen group. Nevertheless, lower pain intensity at 2 hours postdose and longer time using rescue therapy was found in the ibuprofen group without statistical significance. No adverse events occurred over the studied period.