NCT02533908

Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children

Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children: A Prospective, Randomized, Double-blind, Placebo-controlled, Monocentric Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Accepted

Summary

This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.

Detailed description

Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics.

Conditions

• Inhalation of Nitrous Oxide
• Opioid Analgesic Adverse Reaction
• Pain

Interventions

Type	Name	Description
DRUG	Fentanyl intranasal	fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation
DRUG	NaCl 0.9% intranasal	Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation

Timeline

• Start date: 2015-09-21
• Primary completion: 2017-10-12
• Completion: 2017-10-12
• First posted: 2015-08-27
• Last updated: 2017-10-26

Locations

1 site across 1 country: Switzerland