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Ketamine Clinical Trials

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

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Id: ACTRN12616001213437

Organisation Name: Murdoch Children’s Research Institute

Overal Status: Completed

Start Date: 25/10/2016

Brief Summary: We set out to assess the impact of ondansetron on the incidence of vomiting in children undergoing procedural sedation and analgesia (PSA) with the combination of intranasal fentanyl (INF) and inhaled nitrous oxide (N2O) compared with placebo. We hypothesize that ondansetron can significantly decrease the rate of vomiting associated with the combination of INF and N2O. Currently, there exists no report of any strategy to reduce the occurrence of vomiting in patients receiving INF and N2O.

This is a phase III, double-blinded, placebo-controlled superiority trial of ondansetron for prevention of vomiting associated with PSA with the combination of INF and N2O. Participants will be randomized to receive one dose of ondansetron oral syrup (4 mg for patients 15-30 kg; 8 mg for patients >30 kg) or matched placebo during PSA.

The treatment period will be limited to the participants’ emergency visit requiring PSA. The follow-up period will be of a maximum of one week (aiming for less than 72 hours) for each individual, ending at the time of the phone follow-up.

The primary outcome is to determine if ondansetron decreases the incidence of vomiting during PSA with the combination of INF and N2O in children aged between 3 and less than 18 years compared with placebo. Secondary outcomes are to determine the effect of ondansetron compared with placebo on:
a. Number of vomits during PSA
b. Vomiting in the PED after PSA
d. Vomiting within 24 hours of the start of the procedure
c. Retching during PSA
d. Procedure duration
e. Procedure abandonment
f. PSA-associated adverse events during the emergency visit
g. To explore parental satisfaction
h. To explore value parents put on vomiting

• Australia

• vomiting
• sedation