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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild to Moderate Dehydration
• Intervention / Treatment: Drug: Nitrous Oxide

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.

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.

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo CARBAJAL, Md, Phd; Phone Number: +33144736188; Email: ricardo.carbajal@aphp.fr
• Study Contact Backup: Name: Guillaume Masson, Msc; Phone Number: +331 58 41 34 78; Email: guillaume.masson@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75012
      • Recruiting
      • Trousseau Hospital, Pediatric emergency department
      • Contact: Lucie Touchard, nurse; Email: luci.touchard@aphp.fr
      • Principal Investigator: Ricardo CARBAJAL, MD, PhD
    • Poissy, Ile De France, France, 78300
      • Not yet recruiting
      • Poissy Hospital, Pediatric emergency department
      • Contact: Isabelle BADIER, MD; Phone Number: +33 1 39 27 55 91; Email: badier.isa@gmail.com
      • Principal Investigator: Isabelle BADIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Pain; children; infants; analgesia; nitrous oxide; nasogastric tube
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: PHRIP18164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes