CompletedNot Applicable

Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children

France23 participantsStarted 2021-12-10

Plain-language 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.

Who can participate

Age range

3 Months – 3 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain during nasogastric tube insertion

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

Trial details

NCT IDNCT04008628

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-22

View on ClinicalTrials.gov More Mild to Moderate Dehydration trials