Analgesic effects of nefopam in patients undergoing bimaxillary osteotomy: A double-blind, randomized, placebo-controlled study

Abstract

Purpose: Many studies have examined the postoperative analgesic effects of nefopam in various settings. However, although nefopam is expected to be useful in bimaxillary osteotomy, no published data are available.

Material and methods: We divided 42 patients into nefopam [n = 21, nefopam 20 mg intravenous (i.v.) 30 min before surgery, followed by an i.v. infusion (5 mg/h) beginning immediately postoperatively for 24 h] and control [n = 21, normal saline] groups. Then we compared the analgesic efficacy, side effects, and degree of patient satisfaction with postoperative analgesia.

Results: Pain was lower in the nefopam group than in the controls in the recovery room [4.6 (3.0-6.0) vs. 6.0 (5.5-7.0), median (interquartile range), P = 0.002] and on the ward. Fewer patients in the nefopam group required rescue analgesics, and the degree of patient satisfaction was significantly higher in the nefopam group (P < 0.001). There were no significant differences in other side effects between the groups. However, the control group showed more sedation 1 h postoperatively (P = 0.009).

Conclusion: Nefopam is an effective analgesic in bimaxillary osteotomy in that it can reduce the use of opioids and nonsteroidal anti-inflammatory drugs, thereby reducing the side effects of conventional analgesics. (

Trial registration: ClinicalTrials.gov (NCT 01461031)).

Trial registration: ClinicalTrials.gov NCT01461031.

Keywords: Bimaxillary osteotomy; NSAIDs; Nefopam; Opioid; Sedation.