Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology (DOLATSONG)

Centre Hospitalier Sud Francilien

Status: Completed

Conditions: Pain Score

Treatments: Other: the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal; Other: the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier

Study type: Interventional

Funder types: Other

Identifiers

NCT03142230

2015-A00427-42

Details and patient eligibility

About

Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn

Full description

After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn

Enrollment: 71 patients

Sex: All

Ages: 2 to 14 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
• Presence of sucking reflex
• Patient whose authors of parental authority have given their written consent for their participation
• Patient affiliated to or benefiting from a social security scheme

Exclusion criteria

• Newborn intubated or NIV and / or sedated
• Newborn with malformation (especially cleft palate)
• Contra-indication to sugar administration
• Newborn previously included in the study
• Administration of analgesics in the previous 8 hours
• Atresia of the unoperated esophagus
• Non-operated oeso-tracheal fistula
• Major swallowing disorders
• Necrotizing ulcerative colitis

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

non-nutritive suction with holed baby bottle nipple

Experimental group

Description:

A group using the holed baby bottle nipple

Treatment:

Other: the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal

Simple non-nutritive suction with personal pacifier

Active Comparator group

Description:

A group using personal pacifier

Treatment:

Other: the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier