Randomized trial of OFIRMEV versus placebo for pain management after laparoscopic sleeve gastrectomy.

BACKGROUND: OFIRMEV is an intravenous form of acetaminophen approved by the Food and Drug Administration for use as an antipyretic and treatment of mild to moderate pain alone or in conjunction with opioid medications. Intravenous APAP use in postsurgical pain management has been reported to decrease opioid usage, time to rescue dose, and subjective pain.
OBJECTIVES: We used a placebo-controlled, randomized double-blind study to test the efficacy of OFIRMEV in decreasing opioid use and subjective pain after laparoscopic sleeve gastrectomy.
SETTING: U.S. military training hospital.
METHODS: Thirty-four patients who met criteria were enrolled and randomly assigned to 2 separate limbs of the study. The OFIRMEV and placebo groups had similar mean age ranges (48±11 and 50±11 yr) and a female/male ratio of 5:1 and 6:1, respectively. The patients received an intraoperative dose and then postoperative administration of intravenous OFIRMEV 1 g or placebo every 6 hours for 24 hours in addition to fentanyl via patient-controlled analgesia. Subjective pain scores, the total amount of fentanyl used, time to rescue of first narcotic dose, and total postanesthesia care unit (PACU) narcotic use were measured during the first 24 hours after surgery.
RESULTS: Subjective pain score was significantly decreased compared with baseline at 12, 16, and 20 hours after surgery in OFIRMEV-treated patients but not in the placebo group. However, total narcotic use, time to rescue of first narcotic dose, and total PACU narcotic dose were not statistically different between the 2 groups.
CONCLUSION: Intravenous OFIRMEV use caused a modest but statistically significant decrease in subjective pain without affecting narcotic use after laparoscopic sleeve gastrectomy. (Surg Obes Relat Dis 2015;0:000-00.)

RCT Entities:   Population Interventions Outcomes