---
title: Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children
nct_id: NCT02533908
overall_status: COMPLETED
phase: PHASE3
sponsor: "University Children's Hospital, Zurich"
study_type: INTERVENTIONAL
primary_condition: Inhalation of Nitrous Oxide
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02533908.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02533908"
ct_last_update_post_date: 2017-10-26
last_seen_at: "2026-05-12T06:01:00.342Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children

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

**NCT ID:** [NCT02533908](https://clinicaltrials.gov/study/NCT02533908)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 402
- **Lead Sponsor:** University Children's Hospital, Zurich
- **Conditions:** Inhalation of Nitrous Oxide, Opioid Analgesic Adverse Reaction, Pain
- **Start Date:** 2015-09-21
- **Completion Date:** 2017-10-12
- **CT.gov Last Update:** 2017-10-26

## 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.

## 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.

## Eligibility

- **Minimum age:** 2 Years
- **Maximum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Fentanyl intranasal** (ACTIVE_COMPARATOR) — Fentanyl Sintetica 0.1mg/2ml: 1.5ug/kilogram intranasal= 0.03ml/kg once
- **NaCl 0.9% intranasal** (PLACEBO_COMPARATOR) — NaCl 0.9% Sintetica 18mg/2ml: same dosage as fentanyl= 0.03ml/kg

## Interventions

- **Fentanyl intranasal** (DRUG) — fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation
- **NaCl 0.9% intranasal** (DRUG) — Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation

## Primary Outcomes

- **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

- **adverse events of nitrous oxide 70% versus nitrous oxide 70% combined with fentanyl intranasal** _(time frame: up to 18 months)_

## Locations (1)

- Children's Hospital, Zurich, Switzerland

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.children's hospital|zurich||switzerland` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02533908.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02533908*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*