Pain Score
Conditions
Keywords
feeding tube, gastric, newborn infant, nursing, pain
Brief 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
Detailed 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
Interventions
OTHERthe 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
OTHERthe 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
Sponsors
Centre National de Ressources de lutte contre la Douleur
Centre Hospitalier Sud Francilien
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician is not aware of the control and experimental arms, called arms A and B in the results he must analyze.
Intervention model description
Prospective, controlled, randomized, multicentric, open-label, randomized study
Eligibility
Sex/Gender
ALL
Age
2 Days to 14 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain evaluation | Time of nurse care - thirty minutes maximum | DAN SCALE |
Countries
France
Outcome results
None listed