Effect of nefopam- versus fentanyl-based patient-controlled analgesia on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: a prospective double-blind randomized controlled trial

Curr Med Res Opin. 2015 Aug;31(8):1599-607. doi: 10.1185/03007995.2015.1058251. Epub 2015 Jul 9.

Abstract

Objective: This study comparatively evaluated the effect of patient-controlled analgesia (PCA) regimens using equipotent doses of nefopam or fentanyl during laparoscopic gynecological surgery on postoperative nausea and vomiting (PONV).

Research design and methods: Patients undergoing gynecological laparoscopic surgery were randomly allocated to receive either nefopam- (non-opioid; N group) or fentanyl-based (F group) PCA. PONV and postoperative pain were assessed during the 72 hours following discharge from the post-anesthetic care unit (PACU). The adverse effects of nefopam were also evaluated.

Clinical trial registration: Cris.nih.go.kr ID KCT0000783.

Results: In total, 94 patients were included in the final analysis. The PONV incidence and scale and the Rhodes index scores were significantly lower in the N group than the F group at all measured times. The N group exhibited a significantly lower incidence of PONV (15/47 [31.9%] vs. 27/47 [57.4%], respectively; P = 0.022) and severity of PONV (0 [1] vs. 1 [2], respectively; P = 0.005) 24 hours after PACU discharge and a significantly lower Rhodes index score (0 [3] vs. 5 [9], respectively; P = 0.002) from 30 minutes after PACU arrival to 24 hours after PACU discharge than did the F group. There was no significant difference in postoperative pain at any time between the two groups. Dry mouth on PACU arrival was significantly more frequent in the N group. However, the frequency of dry mouth decreased after PACU arrival in the N group, resulting in a significantly lower incidence 24 hours after PACU discharge.

Conclusions: Use of a PCA regimen with nefopam for analgesia was associated with a similar degree of pain control and superior PONV outcomes 24 hours after PACU discharge and no adverse events compared with a PCA regimen using an equipotent dose of fentanyl.

Keywords: Fentanyl; Nefopam; Patient-controlled analgesia; Postoperative nausea and vomiting.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Analgesia, Patient-Controlled*
  • Analgesics, Opioid / administration & dosage*
  • Double-Blind Method
  • Female
  • Fentanyl / administration & dosage*
  • Gynecologic Surgical Procedures*
  • Humans
  • Laparoscopy*
  • Male
  • Middle Aged
  • Nefopam / administration & dosage*
  • Pain, Postoperative / drug therapy*
  • Postoperative Nausea and Vomiting / prevention & control*
  • Prospective Studies

Substances

  • Analgesics, Opioid
  • Nefopam
  • Fentanyl