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Laughing gas may soothe painful tube insertion in toddlers

NCT ID NCT04008628

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial investigates whether inhaling a 50/50 mix of nitrous oxide (laughing gas) and oxygen can reduce pain when a nasogastric tube is placed in children aged 3 months to 3 years. The study includes children with mild to moderate dehydration from conditions like gastroenteritis or bronchiolitis. Pain is measured using a standard scale, and parents also report their own anxiety levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
50/50 nitrous oxide/oxygen mixture (Kalinox)
What this could lead to
If effective, this could offer a simple, fast-acting pain relief option for young children undergoing a common but uncomfortable emergency procedure.
What could go wrong
This is a small, early-phase study with only 23 participants, so results may not apply to all children. The gas may not reduce pain significantly, and side effects like nausea or dizziness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

23 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 3 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 having received in the last 3 months prior to inclusion an ophthalmic gas ( SF6, C3F8, C2F6) * Child with known vitamin B12 deficiency or unsubstituted folic acid. * Child who has had a diving accident. * Child with abdominal gas distension abdominal * Child with gas embolism * Child with pulmonary emphysema Premature discontinuation of study participation : * Parents' request to stop participating in the study. * Insertion of the nasogastric tube is not possible

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Conditions

The condition(s) this trial relates to.

agnosia bronchiolitis gastroenteritis Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild to moderate dehydration

Contacts and locations

Locations

  • Ambroise Paré hospital, Pediatric emergency department

    Boulogne-Billancourt, 92100, France

  • Louis Mourier Hospital, Pediatric emergency department

    Colombes, 92700, France

  • Poissy Hospital, Pediatric emergency department

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

  • Trousseau Hospital, Pediatric emergency department

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

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