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

Phase 3

Completed

• Conditions: Inhalation of Nitrous Oxide; Opioid Analgesic Adverse Reaction; Pain
• Interventions: Drug: NaCl 0.9% intranasal; Drug: Fentanyl intranasal

• Registration Number: NCT02533908
• Lead Sponsor: University Children's Hospital, Zurich

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Study Start: 2015-09-21
• Status Verified: 2016-10
• Primary Completion: 2017-10-12
• Study Completion: 2017-10-12
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• indication for nitrous oxide 70% application
• boys/girls aged 2-16 years
• informed consent

Exclusion Criteria

• due to language barrier no sufficient communication possible to explain the study
• incompatibility to Fentanyl Sintetica
• incompatibility to morphinomimetics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9% intranasal	NaCl 0.9% intranasal	NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg
Fentanyl intranasal	Fentanyl intranasal	Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score	up to 18 months	the Patient is videotaped during the painful procedure and afterwards the video is analysed using the FLACC score. Each category is scored on a 0-2 scale (5 categories) which results in a total score of 0 (no pain) -10 (severe pain).

Secondary Outcome Measures

Name	Time	Method
adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal	up to 18 months

Trial Locations

Locations (1)

Children's Hospital; 🇨🇭 Zurich, Switzerland