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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Mild to Moderate Dehydration

Treatments: Drug: Nitrous Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT04008628

PHRIP18164

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 3 months to 3 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Nitrous oxide

Active Comparator group

Description:

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

Treatment:

Drug: Nitrous Oxide

Standard care

No Intervention group

Description:

Infants will be reassured as currently performed in routine clinical practice