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

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ClinicalTrials.gov Identifier: NCT02533908
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inhalation of Nitrous Oxide Opioid Analgesic Adverse Reaction Pain Drug: Fentanyl intranasal Drug: NaCl 0.9% intranasal Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children: A Prospective, Randomized, Double-blind, Placebo-controlled, Monocentric Study
Study Start Date : September 21, 2015
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : October 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fentanyl intranasal
Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once
Drug: Fentanyl intranasal
fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation
Other Name: Fentanyl Sintetica

Placebo Comparator: NaCl 0.9% intranasal
NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg
Drug: NaCl 0.9% intranasal
Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation
Other Name: NaCl 0.9% Sintetica




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal [ Time Frame: up to 18 months ]


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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533908


Locations
Switzerland
Children's Hospital
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Michelle Seiler University Children's Hospital of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02533908     History of Changes
Other Study ID Numbers: Fentanyl-2015
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fentanyl
Nitrous Oxide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation
Analgesics, Non-Narcotic