ORIGINAL RESEARCH article
Front. Med.
Sec. Intensive Care Medicine and Anesthesiology
Optimal Dosing Regimen of Ondansetron Oral Soluble Pellicles for Preventing Postoperative Nausea and Vomiting after Primary Total Joint Arthroplasty: A Randomized Controlled Clinical Trial
Provisionally accepted
- 1Department of Orthopedics and Research Institute of Orthopedics, West China Hospital, Sichuan University, Chengdu, 610041, China, Chengdu, China
- 2Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, 610041, China., Chengdu, China
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Background The widespread use of high-dose antifibrinolytic agents (tranexamic acid) and opioids in total joint arthroplasty (TJA) has highlighted a critical concern: postoperative nausea and vomiting (PONV). Ondansetron, recognized as a cornerstone for PONV prevention in clinical guidelines, offers an innovative solution through its oral soluble pellicle (OSP) formulation. We conducted this study to investigate the optimal dosing regimen of ondansetron OSP for preventing PONV following primary TJA. Methods This randomized, controlled, double-masked clinical trial allocated 198 patients to three intervention groups: (1) Preop 16mg group: two ondansetron OSP (16 mg) orally 1 hour pre-induction, followed by placebo films at 6 and 12 hours postoperatively; (2) 16+8 mg group: two ondansetron OSP (16 mg) , followed by one ondansetron OSP (8 mg) at 6 hours and one placebo film at 12 hours postoperatively; (3) 8+8+8 mg group: one ondansetron OSP (8 mg) and one placebo film, followed by one ondansetron OSP (8 mg) at both 6 and 12 hours postoperatively. The primary outcome assessed the incidence and severity of PONV within 48 hours after TJA. Secondary outcomes included the utilization frequency of rescue metoclopramide and tramadol, along with adverse drug reactions (ADRs). Results Primary outcomes demonstrated that both the Preop 16mg and 16+8 mg groups achieved significantly lower incidences of postoperative nausea compared to the 8+8+8 mg group, though no statistically significant differences were observed among the three groups in nausea severity (VAS scores) or postoperative vomiting frequency; secondary outcomes showed significantly reduced metoclopramide utilization in the 16+8 mg group versus the 8+8+8 mg group, with a non-significant trend in the Preop 16mg group, while tramadol usage and ADRs rates showed no significant intergroup differences. Conclusions Compared to the 8+8+8 mg regimen, both the Preop 16mg and 16+8 mg dosing strategies demonstrated superior efficacy. For high-risk patients, the 16+8 mg regimen may represent the optimal therapeutic approach.
Keywords: total joint arthroplasty, Postoperative Nausea and Vomiting, ondansetron oral soluble pellicles, Optimal dosing, Clinical significance
Received: 24 Sep 2025; Accepted: 10 Nov 2025.
Copyright: © 2025 Wang, Zhong, Zhao, Zhou and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Haoyang Wang, wanghaoyang-scu@163.com
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