Clinical trial NCT04008628: Nitrous Oxide for Analgesia During Nasogastric Tube Placement in Young Children
Official title: Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild to Moderate Dehydration
Keywords: Pain
nasogastric tube
children
infants
analgesia
nitrous oxide
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: URC-CIC Paris Descartes Necker Cochin
First posted: 2019-07-05
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain during nasogastric tube insertion
timeFrame: From the beginning of the procedures until 2 minutes after final positioning of the tube
Secondary outcomes:
measure: Parent's anxiety 10 scale.
timeFrame: During procedure
measure: Child's constraint needed during the procedure
timeFrame: During procedure
measure: 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.
timeFrame: from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation
Other outcomes:
Locations:
city: Paris
country: France
facility: Trousseau Hospital, Pediatric emergency department
state: Ile De France
city: Poissy
country: France
facility: Poissy Hospital, Pediatric emergency department
state: Ile De France
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré hospital, Pediatric emergency department
city: Colombes
country: France
facility: Louis Mourier Hospital, Pediatric emergency department
Study officials:
affiliation: Trousseau Hospital, pediatric emergency
name: Marie Beauchet-Filleau, nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Trousseau Hospital, pediatric emergency
name: Ricardo Carbajal, Professor
role: STUDY_DIRECTOR
References: