Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children

NCT04008628 | Completed

• 1 other identifier: APHP190210
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children. The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.

Conditions

Mild to Moderate Dehydration

Keywords

Pain; nasogastric tube; children; infants; analgesia; nitrous oxide

Outcome Measures

Primary Outcomes (1)

• Pain during nasogastric tube insertion

  Pain will be assessed during nasogastric tube insertion with the Face Legs Activity Cry Consolability (FLACC) scale composed of five scale (face, legs, activities, shouting, consolability). Each ranks from 0 to 2 : 0 is no pain, 1 is average pain, 2 is a strong pain The outcome measure is the sum of these five subscales: from 0 (better outcome) to 10 (worse outcome).

  From the beginning of the procedures until 2 minutes after final positioning of the tube

Secondary Outcomes (3)

• Parent's anxiety 10 scale.

  During procedure

• Child's constraint needed during the procedure

  During procedure

• The potential side effects of the mixture 50%/50% nitrous oxide/oxygen for a brief inhalation are : Euphoria, dreaming, hallucinations, sedation, headaches, nausea, and vomiting.

  from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation

Study Arms (2)

Nitrous oxide

ACTIVE COMPARATOR

Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure

Drug: Nitrous Oxide

Standard care

NO INTERVENTION

Infants will be reassured as currently performed in routine clinical practice

Interventions

Nitrous Oxide DRUG

Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)

Nitrous oxide

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child from 3 months to 3 years old.
• Admission to the Pediatric Emergency Department
• Medical prescription for the insertion of a nasogastric tube.
• Child with gastroenteritis and / or bronchiolitis and / or food intolerance with mild to moderate dehydration
• Parental presence and parental consent

You may not qualify if:

• Vital emergency.
• Refusal of parents to be filmed or to have their child filmed.
• Child already included in the study or in course of participation in another study.
• Tube placement performed by a medical student or nursing student.
• Patient requiring 100% oxygen ventilation.
• No social security.
• Child with a mental handicap or known retardation.
• History of child intolerance to Nitrous oxide ( excessive sedation or respiratory depression during previous use).
• Child with head trauma in the previous 3 days.
• Child with new-onset neurological abnormalities or other altered states of consciousness.
• Child with intracranial hypertension.
• Child with pneumothorax
• Child with known vitamin B12 deficiency or unsubstituted folic acid.
• Child who has had a diving accident.
• Child with abdominal gas distension abdominal

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (4)

Ambroise Paré hospital, Pediatric emergency department

Boulogne-Billancourt, 92100, France

Location

Louis Mourier Hospital, Pediatric emergency department

Colombes, 92700, France

Location

Trousseau Hospital, Pediatric emergency department

Paris, Île-de-France Region, 75012, France

Location

Poissy Hospital, Pediatric emergency department

Poissy, Île-de-France Region, 78300, France

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Marie Beauchet-Filleau, nurse

  Trousseau Hospital, pediatric emergency

  PRINCIPAL INVESTIGATOR

• Ricardo Carbajal, Professor

  Trousseau Hospital, pediatric emergency

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome will be assessed on video recordings of the procedures which will be prepared so that assessors will not know to which group the children assigned. This correspond to a blind assessment of the primary outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: December 10, 2021
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)