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

Pain Score Clinical Trial

— DOLATSONG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142230
• Other study ID #: 2015-A00427-42
• Status: Completed
• Phase: N/A
• Start date: October 14, 2016
• Est. completion date: August 13, 2018

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain Score

Intervention

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
The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple
• 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
The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	Groupe Hospitalier Paris Saint-Joseph	Paris
France	Centre Hospitalier de Saint-Denis	Saint-Denis

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien	Centre National de Ressources de lutte contre la Douleur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain evaluation	DAN SCALE	Time of nurse care - thirty minutes maximum