Background and Goal of Study: To evaluate the analgesic efficacy in the immediate postoperative setting of 2g of i.v. paracetamol (IVAPAP) compared to the recommended 1g dose; the hypothesis being that the loading dose would result in superior efficacy, as measured by the summed pain relief over 6h (TOTPAR6).
Materials and Methods: Single center, randomized, double-blind, placebocontrolled, 3-parallel group study. Patients with moderate to severe pain (4-point verbal scale (VS)) and 40 mm (100 mm visual analogue scale (VAS)) following surgical removal of an impacted third molar received IVAPAP 2g or 1g or placebo (15min infusion). Pain relief (5-point VS), pain intensity (VS, VAS), time to remedication, patient global evaluation, adverse events, vital signs and biological tests were evaluated over 8h.
Results and Discussions: 297 patients (132 = 2g; 132 = 1g; 33 = placebo) were randomized. TOTPAR6 was significantly superior with 2g: 10.2 ± 6.5 versus 1g: 7.1 ± 5.9 versus placebo: 2.8 ± 4.4 (p < 0.0001). Comparable results were observed over 8h. Pain relief and pain intensity difference scores of 2g were significantly superior to 1g from T30' to T8h and to placebo from T15' to T8h. Median time to remedication was significantly longer with 2g: 5h 02min, versus 1g: 3h 14min, placebo: 1h 02min. No statistically significant difference was observed between the 3 groups regarding the safety profile.
Conclusions: A superior analgesic efficacy of 2g of injectable paracetamol over the recommended dose of 1g was demonstrated following third molar surgery in terms of magnitude and duration of analgesic effect, with no difference in terms of safety between groups.
Acknowledgement: Supported by a grant from Bristol-Myers Squibb/UPSA.