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

NCT02533908 | Completed Phase 3 DMC

• 1 other identifier: Fentanyl-2015
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalation of Nitrous Oxide; Opioid Analgesic Adverse Reaction; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal

  up to 18 months

Study Arms (2)

Fentanyl intranasal

ACTIVE COMPARATOR

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

Drug: Fentanyl intranasal

NaCl 0.9% intranasal

PLACEBO COMPARATOR

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

Drug: NaCl 0.9% intranasal

Interventions

Fentanyl intranasal DRUG

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

Also known as: Fentanyl Sintetica

Fentanyl intranasal

NaCl 0.9% intranasal DRUG

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

Also known as: NaCl 0.9% Sintetica

NaCl 0.9% intranasal

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

Children's Hospital

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30630844 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Seiler

  University Children's Hospital of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 27, 2015
• Study Start: September 21, 2015
• Primary Completion: October 12, 2017
• Study Completion: October 12, 2017
• Last Updated: October 26, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)