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

Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02533908
• Study type: Interventional
• Source: University Children's Hospital, Zurich
• Status: Completed
• Phase: Phase 3
• Start date: September 21, 2015
• Completion date: October 12, 2017