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NCT Number: NCT02533908

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

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.

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Key information

Conditions

Inhalation of Nitrous Oxide Neurologic Manifestations Opioid Analgesic Adverse Reaction Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl intranasal

Drug

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

Other names: Fentanyl Sintetica

NaCl 0.9% intranasal

Drug

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

Other names: NaCl 0.9% Sintetica

Primary outcomes

  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 outcomes

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

    Time frame: up to 18 months

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 27, 2015
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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