Mild to Moderate Dehydration Clinical Trial
— SONGEROfficial title:
Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years
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.
| Status | Recruiting |
| Enrollment | 160 |
| Est. completion date | December 2023 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Months to 3 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Ambroise Paré hospital, Pediatric emergency department | Boulogne-Billancourt | |
| France | Louis Mourier Hospital, Pediatric emergency department | Colombes | |
| France | Trousseau Hospital, Pediatric emergency department | Paris | Ile De France |
| France | Poissy Hospital, Pediatric emergency department | Poissy | Ile De France |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | URC-CIC Paris Descartes Necker Cochin |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Parent's anxiety 10 scale. | The parent evaluates himself his anxiety. It's a simple scale graduate one by one, from 0 (better outcome) to 10 (worse outcome). Based on their subjective interpretation of their own anxiety | During procedure | |
| Secondary | Child's constraint needed during the procedure | Scale for grading the level of constraint during the procedure It is composed to three subscales from 0 to 3 (head, arms, legs). 0 is no contention, 1 is soft hold, 2 is firm support, 3 is very firm hold And one subscale from 0 to 1 (trunk). 0 is no contention, 1 is necessary maintenance.
The outcome measure is the sum of these four subscales: from 0 (better outcome, that is to say no contention) to 10 (strongest contention). |
During procedure | |
| Secondary | 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. | The rate of side effects will be described | from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation |