Protocol for a double blind, randomised placebo-controlled trial using ondansetron to reduce vomiting in children receiving intranasal fentanyl and inhaled nitrous oxide for procedural sedation in the emergency department (the FON trial).

ABSTRACT:

Introduction

Intranasal fentanyl and nitrous oxide (N₂O) can be combined to create a non-parenteral procedural sedation regimen for children in the paediatric emergency department. This combination of intranasal fentanyl and N₂O provides effective pain relief for more painful procedures, but is associated with a higher incidence of vomiting than N₂O alone. Our aim is to assess whether ondansetron used preventatively reduces the incidence of vomiting associated with intranasal fentanyl and N₂O for procedural sedation compared with placebo.

Methods and analysis

This study is a double blind, randomised placebo-controlled superiority trial. This is a single-centre trial of 442 children aged 3-18 years presenting to a tertiary care Paed

SUBMITTER: Fauteux-Lamarre E 

PROVIDER: S-EPMC5843010 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature