The analgesic efficacy of tramadol in ambulatory gynecological laparoscopic procedures: a randomized controlled trial.

BACKGROUND: To evaluate the postoperative analgesic efficacy of intravenous tramadol 50 mg administered before anesthetic induction in patients undergoing ambulatory gynecological laparoscopic procedures. METHODS: This was a double-blind randomized, controlled trial conducted in 150 patients. Pain intensity was measured using a verbal numerical rating score at 1, 2, 6, 12, and 24 h postoperatively and at discharge. Requirement of analgesics (fentanyl and paracetamol), effect of pain on sleep, activity limitation, side effects (headache, dizziness, drowsiness, nausea, vomiting, and dry mouth), global perceived analgesic efficacy, satisfaction, and preference for stronger analgesics were assessed in the first 24 h postoperatively. RESULTS: There were no statistical differences between the tramadol group and the placebo group in terms of clinical data and pain intensity at any measured times. Recovery room data showed no statistical differences regarding number of patients requiring fentanyl, time to first fentanyl requirement, total fentanyl required, verbal numerical rating score before fentanyl administration, and incidence of nausea/vomiting and shivering. Post-discharge data showed that patients in the tramadol group required statistically less paracetamol (3.2 vs. 3.9 tablets, P = 0.04). There were no statistical differences regarding the number of patients requiring paracetamol, verbal numerical rating score before taking paracetamol, effect of pain on sleep and activity, global perceived analgesic efficacy, satisfaction, preference for stronger analgesics, and side effects. CONCLUSION: Intravenous tramadol 50 mg given before anesthetic induction did not reduce pain intensity but was well tolerated. Although tramadol statistically reduced the paracetamol requirement in the first 24 h postoperatively, it did not seem to provide a significant clinical advantage.