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

NCT ID: NCT02533908

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-21

Study Completion Date

2017-10-12

Brief Summary

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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

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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

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Inhalation of Nitrous Oxide Opioid Analgesic Adverse Reaction Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fentanyl intranasal

Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once

Group Type ACTIVE_COMPARATOR

Fentanyl intranasal

Intervention Type DRUG

fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation

NaCl 0.9% intranasal

NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg

Group Type PLACEBO_COMPARATOR

NaCl 0.9% intranasal

Intervention Type DRUG

Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation

Interventions

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Fentanyl intranasal

fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation

Intervention Type DRUG

NaCl 0.9% intranasal

Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation

Intervention Type DRUG

Other Intervention Names

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Fentanyl Sintetica NaCl 0.9% Sintetica

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Seiler

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital of Zurich

Locations

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Children's Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Seiler M, Staubli G, Landolt MA. Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial. Emerg Med J. 2019 Mar;36(3):142-147. doi: 10.1136/emermed-2018-207892. Epub 2019 Jan 10.

Reference Type DERIVED
PMID: 30630844 (View on PubMed)

Other Identifiers

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Fentanyl-2015

Identifier Type: -

Identifier Source: org_study_id