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Completed

NCT Number: NCT04008628

Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children

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.

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Key information

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trousseau Hospital, Pediatric emergency department, Paris, Île-de-France Region, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 possible

Treatment and study plan

Nitrous Oxide

Drug

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

Primary outcomes

  1. Pain during nasogastric tube insertion

    Time frame: 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 outcomes

  1. Parent's anxiety 10 scale.

    Time frame: 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

  2. Child's constraint needed during the procedure

    Time frame: 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).

  3. 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.

    Time frame: from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation

    The rate of side effects will be described

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: SONGER

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2019
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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