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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533908
• Other study ID #: Fentanyl-2015
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2015
• Last updated: October 25, 2017
• Start date: September 21, 2015
• Est. completion date: October 12, 2017

Study information

• Verified date: October 2016
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: October 12, 2017
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Switzerland	Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score	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).	up to 18 months
Secondary	adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal		up to 18 months