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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 12, 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Fentanyl intranasal
    • Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once
  • Placebo Comparator: NaCl 0.9% intranasal
    • NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg

Clinical Trial Outcome Measures

Primary Measures

  • Analgesic efficacy of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal using the FLACC score
    • Time Frame: 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 Measures

  • adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal
    • Time Frame: up to 18 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Children’s Hospital, Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michelle Seiler, Principal Investigator, University Children’s Hospital of Zurich

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