Ondansetron to reduce vomiting in children receiving intranasal fentanyl and inhaled nitrous oxide for procedural sedation: a double blind, randomised placebo controlled trial

Phase 3

Completed

• Conditions: vomiting; sedation; Anaesthesiology - Other anaesthesiology; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12616001213437
• Lead Sponsor: Murdoch Children’s Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-01
• Study Completion: 2019-01-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

1. Be aged from 3 years to 18 years
2. Weight equal or greater than 15 kg
3. Planned procedural sedation with the combination of intranasal fentanyl and nitrous oxide
4. Have written informed consent provided by a parent or legal guardian. The participant may
also provide consent if he/she is deemed competent.

Exclusion Criteria

1. Contraindication to receiving intranasal fentanyl: opioid allergy and acute/chronic nasal
problems
2. Contraindication to receiving nitrous oxide as per institutional sedation manual
3. Contraindication to receiving ondansetron or placebo: known arrhythmia, use of QT-
prolonging drugs or allergy to any component of the ondansetron or placebo syrups
4. Cardiorespiratory instability
5. Decreased level of consciousness
6. Concomitant head injury
7. Planned use of additional sedatives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of vomiting from beginning of procedural sedation with intranasal fentanyl and nitrous oxide until discharge from the paediatric emergency department or within one hour from the procedure (whichever comes first). This outcome will be recorded on the case report form by the medical staff caring for the participant during the emergency visit.[From beginning of procedure, defined as time of nitrous oxide mask application, until discharge from the paediatric emergency department or within one hour from the procedure (whichever comes first).]