Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years

PHRIP18164

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.

2021-12-10

2023-12-01

2023-12-01

Recruiting

160

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. * Refusal of parents to be 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 Premature discontinuation of study participation : * Parents' request to stop participating in the study. * Insertion of the nasogastric tube is not possible

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

2023-02-03