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Intravenous ondansetron in established postoperative emesis in children. S3A-381 Study Group
S Khalil1, A Rodarte, B C Weldon
1Department of Anesthesiology, University of Texas Houston Health Science Center 77030, USA.
Insights
Ondansetron effectively controlled postoperative vomiting in children after outpatient surgery, reducing emesis and enabling quicker discharge. This treatment was well-tolerated with similar adverse events compared to placebo.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Surgical Care
Background:
- Postoperative vomiting is common in pediatric surgical patients.
- It can delay recovery and lead to hospital readmission.
- Effective antiemetic strategies are crucial for outpatient surgery recovery.
Purpose of the Study:
- To evaluate the efficacy and safety of ondansetron for established postoperative emesis in children.
- To compare ondansetron with placebo in pediatric outpatients aged 2-12 years.
- To assess the impact of ondansetron on recovery time and hospital discharge.
Main Methods:
- A randomized, double-blind, placebo-controlled, multicenter study.
- 2,720 children (ASA I-III) undergoing outpatient surgery with general anesthesia were screened.
- Children with two emetic episodes within 2 hours received intravenous ondansetron (0.1 mg/kg or 4 mg) or placebo.
Main Results:
- Significantly more children in the ondansetron group had no emetic episodes or rescue medication use at 2 and 24 hours (78% vs 34% at 2h; 53% vs 17% at 24h).
- Median time to emesis or rescue medication was longer with ondansetron (127 min vs 58 min).
- Ondansetron group had a significantly shorter median time to discharge (153 min vs 173 min).
- Adverse event incidence was similar between groups (3% ondansetron vs 4% placebo).
Conclusions:
- A single dose of ondansetron is effective and well-tolerated for preventing further postoperative emesis in pediatric outpatients.
- Ondansetron administration can lead to a shorter time to patient discharge.
- Ondansetron represents a valuable option for managing postoperative nausea and vomiting in children.
Background:
In pediatric postsurgical patients, postoperative vomiting is a common occurrence that can delay recovery and result in unplanned hospital admissions after outpatient surgery. This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of ondansetron in the control of established postoperative emesis in outpatients aged 2-12 yr.
Methods:
Screened for the study were 2,720 ASA physical status 1-3 children undergoing outpatient surgery during general anesthesia, which included nitrous oxide. Children experiencing two emetic episodes within 2 h of discontinuation of nitrous oxide were given intravenous ondansetron (n = 192; 0.1 mg/kg for children weighing < or = 40 kg; 4 mg for children weighing > 40 kg) or placebo (n = 183).
Results:
The proportion of children with no emetic episodes and no use of rescue medication was significantly greater (P < 0.001) in the ondansetron group compared with placebo for both 2- and 24-h periods after study drug administration (78% of the ondansetron group and 34% of the placebo group for 2 h; 53% of the ondansetron group and 17% of the placebo group for 24 h). Among patients with at least one emetic episode or with rescue medication use, the median time to onset of emesis or rescue was 127 min in the ondansetron group compared with 58 min in the placebo group (P < 0.001). The median time from study drug administration until discharge was significantly shorter (P < 0.01) in the ondansetron group (153 min, range 44-593 min) compared with the placebo group (173 min, range 82-622 min). The incidence of potentially drug-related adverse events was similar in the ondansetron (3% of patients) and the placebo (4% of patients) groups.
Conclusion:
A single dose of ondansetron (0.1 mg/kg up to 4 mg) is effective and well tolerated in the prevention of further episodes of postoperative emesis in children after outpatient surgery. Administration of ondansetron also may result in a shorter time to discharge.