SONGER: Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04008628

Collaborator

URC-CIC Paris Descartes Necker Cochin (Other)

160

Enrollment

Locations

Arms

11.7

Anticipated Duration (Months)

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild to Moderate Dehydration	Drug: Nitrous Oxide	N/A

Detailed Description

In the context of mild to moderate dehydration in young children, enteral rehydration is the treatment of choice because it is more physiological than parenteral rehydration which has more serious side effects. Thus, nasogastric tube placement has become a more common procedure in the pediatric emergency care setting. Although, it is widely accepted that this procedure is invasive and painful, to date, no analgesic approach has been shown to be effective for children aged 3 months to 3 years. Currently, standard care is the placement of nasogastric tube without any analgesic intervention.

Inhalation of nitrous oxide mixed with oxygen (50/50) has been shown to be effective to reduce pain and anxiety induced by invasive procedures in children, adolescents and adults. Its use is very safe and it is associated with only minor and transient side effects such as nausea, vomiting or dizziness in les than 10% of patients. Its use is very common in many countries such as France, United Kingdom, The Netherlands or Australia. The investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.

A randomized controlled trial will be performed in two pediatric emergency departments to assess the efficacy of 50/50 nitrous oxide/oxygen during nasogastric tube insertion. The control group will receive standard care.

Primary outcome: Pain assessed with the FLACC scale during tube insertion

The investigators believe that this randomized study comparing nitrous oxide inhalation against current practice (no analgesic means) will highlight the intensity of pain caused by nasogastric tube placement and will assess the effectiveness of nitrous oxide inhalation to reduce pain and anxiety induced by the procedure

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 10, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nitrous oxide Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure	Drug: Nitrous Oxide Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)
No Intervention: Standard care Infants will be reassured as currently performed in routine clinical practice

Arm

Intervention/Treatment

Active Comparator: Nitrous oxide

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

Drug: Nitrous Oxide

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

No Intervention: Standard care

Infants will be reassured as currently performed in routine clinical practice

Outcome Measures

Primary Outcome Measures

Pain during nasogastric tube insertion [From the beginning of the procedures until 2 minutes after final positioning of the tube]
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).

Secondary Outcome Measures

Parent's anxiety 10 scale. [During procedure]
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
Child's constraint needed during the procedure [During 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).
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]
The rate of side effects will be described

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trousseau Hospital, Pediatric emergency department	Paris	Ile De France	France	75012
2	Poissy Hospital, Pediatric emergency department	Poissy	Ile De France	France	78300

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin

Investigators

Principal Investigator: Marie Beauchet-Filleau, nurse, Trousseau Hospital, pediatric emergency
Study Director: Ricardo Carbajal, Professor, Trousseau Hospital, pediatric emergency