What is the clinical evidence from this study?

Study design: RCT. Population: Procedural sedation and analgesia (n=63). Intervention: Oral ondansetron vs. Placebo. Primary outcome: Vomiting in the emergency department (difference -3.8%, 95% CI -23.8% to 16.2%, p=0.707).

December 30, 2014Pediatric Emergency Medicine JournalOpen Access

Effect of Oral Ondansetron on Vomiting Associated with Intramuscular Ketamine Sedation in Children: A Double-Blind, Randomized, Placebo-Controlled Trial

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Key result

Oral ondansetron fails to reduce ED vomiting vs placebo in children receiving ketamine sedation.

difference -3.8%
95% CI -23.8% to 16.2%
P=0.707
n=63

Why the study?

Does oral ondansetron reduce vomiting in children receiving intramuscular ketamine sedation?

Population

63 children receiving intramuscular ketamine for procedural sedation and analgesia in a children's hospital…

Comparison

Oral ondansetron administered 15 minutes before… vs Placebo administered 15 minutes before ketamine…

Design

RCT, randomized, double-blind, placebo-controlled

Follow-up

up to 12 hours after discharge

Authors

JCJea Yeon ChoiGachon University Gil Medical Center YKYoung Ho KwakSeoul National University DKDo Kyun KimPusan National University Yangsan Hospital

Discussion

Member takes

Implication

Does not support routine ondansetron prophylaxis with IM ketamine sedation in children; confirms lack of antiemetic efficacy in this RCT.

Study Design

Type

RCT (n=63)

Blinding

Double-blind

Randomization

1:1 ratio, stratified by fasting duration

Multicenter

Structured PICO

Does oral ondansetron reduce vomiting in children receiving intramuscular ketamine sedation?

Population

63 children under 8 years of age receiving intramuscular ketamine for procedural sedation and analgesia in a pediatric emergency department, randomized to oral ondansetron or placebo.

Intervention

Oral ondansetron (2 mg or 4 mg) administered 15 minutes before ketamine injection.

Comparator

Placebo administered 15 minutes before ketamine injection.

Outcome

Incidence of vomiting in the ED postsedation or up to 12 hours after discharge.safety

Main Result

Effect estimate: difference -3.8% (95% CI -23.8% to 16.2%)

Absolute Event Rate: 22.6% vs 18.8%

Absolute Risk Reduction: -3.8%

p-value: p=0.707

Prophylactic oral ondansetron does not significantly reduce the incidence of vomiting in children receiving intramuscular ketamine for procedural sedation.

Limitations

Selection bias due to convenience sampling in a busy emergency department environment.
Single-center study with a small sample size, which may have lacked statistical power to detect a significant difference.
The 15-minute interval between oral ondansetron administration and ketamine injection may not have been sufficient for the antiemetic effect to fully manifest.

Cite This Study

Choi et al. (2014) conducted an RCT in Procedural sedation and analgesia (n=63). Oral ondansetron vs. Placebo was evaluated on Vomiting in the emergency department (difference -3.8%, 95% CI -23.8% to 16.2%, p=0.707). Oral ondansetron did not significantly reduce the incidence of vomiting in the emergency department compared to placebo in children receiving intramuscular ketamine for procedural sedation (22.6% vs 18.8%, p=0.707).

synapsesocial.com/papers/6aa25e4f3c35dfb37e206865 https://doi.org/10.22470/pemj.2014.1.2.83

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Effect of Oral Ondansetron on Vomiting Associated with Intramuscular Ketamine Sedation in Children: A Double-Blind, Randomized, Placebo-Controlled Trial

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Effect of Oral Ondansetron on Vomiting Associated with Intramuscular Ketamine Sedation in Children: A Double-Blind, Randomized, Placebo-Controlled Trial

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider