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

Study Overview
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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.

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

Conditions
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Inhalation of Nitrous Oxide, Opioid Analgesic Adverse Reaction, Pain

Intervention / Treatment
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* Drug: Fentanyl intranasal
* Drug: NaCl 0.9% intranasal


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl intranasal<br>Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once | Drug: Fentanyl intranasal<br>* fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation<br>* Other names: Fentanyl Sintetica;|
| Placebo Comparator: NaCl 0.9% intranasal<br>NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg | Drug: NaCl 0.9% intranasal<br>* Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation<br>* Other names: NaCl 0.9% Sintetica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal |  | up to 18 months |