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.
