Efficacy of orally disintegrating film of ondansetron versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing elective gynaecological laparoscopic procedures: a prospective randomised, double‐blind placebo‐controlled study

Content Provider	SDM College of Medical Sciences & Hospital, Dharwad
Author	Hegde, Harihar V. Yaliwal, Vijay G. Annigeri, Rashmi V. Sunilkumar, K. S. R., Ramesh Kumar Rao, Raghavendra P.
Abstract	Ondansetron is one of the most widely used drugs for postoperative nausea and vomiting (PONV) prophylaxis. Orally disintegrating film (ODF) formulations are relatively recent innovations. We evaluated the efficacy of ODF of ondansetron for the prophylaxis of PONV. Methods: One hundred and eighty American Society of Anaesthesiologists‐I or II women, in the age group 18-65 years, scheduled for elective gynaecological laparoscopic procedures were studied in a prospective randomised, double‐blind, placebo‐controlled trial. The patients were randomised into four groups: Placebo, intravenous (IV) ondansetron 4 mg, ODF of ondansetron 4 mg (ODF4) and 8 mg (ODF8) groups. PONV was assessed in two epochs of 0-6 and 7-24 h. Primary outcome measure was the incidence of PONV and secondary outcome measures were severity of nausea, need for rescue anti‐emetic, analgesic consumption, time to oral intake, overall patient satisfaction and side effects such as headache and dizziness. PONV was compared using analysis of variance or Mann–Whitney U‐test as applicable. Results: Data of 173 patients were analysed. The incidence of postoperative nausea was significantly lower (P = 0.04) only during the 0-6 h in the ODF8 group when compared with the placebo group. During the 0-6 h interval postoperatively, the ODF8 group had a significantly lower incidence of vomiting when compared with the placebo (P = 0.002) and the IV group (P = 0.044). During the 0-24 h interval postoperatively, ODF4 (P = 0.01) and ODF8 (P = 0.002) groups had a significantly lower incidence of vomiting compared to the placebo group. Conclusions: Orally disintegrating film of ondansetron is an efficacious, novel, convenient and may be a cost‐effective option for the prophylaxis of PONV.
Starting Page	423
Ending Page	429
Page Count	7
File Format	PDF
ISSN	00195049
Journal	Indian Journal of Anaesthesia
Volume Number	58
Issue Number	4
e-ISSN	09762817
Language	English
Publisher	Wolters Kluwer - Medknow
Access Restriction	Limited
Subject Keyword	Laparoscopic surgical procedures Ondansetron Postoperative nausea and vomiting Randomized controlled trial
Content Type	Text
Resource Type	Article
Subject	Anesthesiology and Pain Medicine