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| Name | Class |
|---|---|
| Centre National de Ressources de lutte contre la Douleur | UNKNOWN |
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Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-nutritive suction with holed baby bottle nipple | Experimental | A group using the holed baby bottle nipple |
|
| Simple non-nutritive suction with personal pacifier | Active Comparator | A group using personal pacifier |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple |
| Measure | Description | Time Frame |
|---|---|---|
| pain evaluation | DAN SCALE | Time of nurse care - thirty minutes maximum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Granier, MD | Centre Hospitalier Sud Francilien | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91106 | France | |||
| Groupe Hospitalier Paris Saint-Joseph |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38833575 | Derived | Darretain H, Laborne FX, Lagadec S, Garrigue B, Maillard F, Harbi F, Waszak P, Granier M, Galand N, Walter-Nicolet E, Razafimahefa H. An Analgesic Technique for Orogastric Tube Insertion in Newborns: DOLATSONG, a Randomized Multicentric Controlled Trial. J Perinat Neonatal Nurs. 2024 Oct-Dec 01;38(4):361-368. doi: 10.1097/JPN.0000000000000746. Epub 2024 Nov 7. |
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Prospective, controlled, randomized, multicentric, open-label, randomized study
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The statistician is not aware of the control and experimental arms, called arms A and B in the results he must analyze.
|
| 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 | Other | The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier |
|
| Paris |
| 75014 |
| France |
| Centre Hospitalier de Saint-Denis | Saint-Denis | 93200 | France |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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