"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants (Casa)
"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.
Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.
Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Hospitalization at CHU de la Réunion - site sud in Neonatal Intensive Care Unit or Neonatology Unit. (Neonate reanimation, pediatric reanimation or Neonatology services)
- Informed consent from holder(s) of the parental authority
Exclusion Criteria:
- Intubated ou sedated patients
- Treated with a combined analgesic during venipuncture
- Having indications against sucrose
- For which behavorial items from DAN scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Holding-cuddling + Sucrose
The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling.
|
The "Holding-cuddling" is started 5 minutes before veinipuncture.
The sucrose adminstration is started 2 minutes before veinipuncture.
|
|
Comparateur actif: Sucrose alone
The sucrose administration is started 2 minutes before blood sampling.
|
The sucrose adminstration is started 2 minutes before veinipuncture.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evolution of Pain
Délai: At 0 and 30 seconds after the veinopuncture
|
Measure of pain by DAN scale at the time of the veinopuncture
|
At 0 and 30 seconds after the veinopuncture
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cardiac Frequency
Délai: At 0 and 30 seconds after veinopuncture
|
Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after
|
At 0 and 30 seconds after veinopuncture
|
|
Oxygen saturation
Délai: At 0 and 30 seconds after veinopuncture
|
Measure of the oxygen saturation at the time of the veinopuncture and 30 seconds after
|
At 0 and 30 seconds after veinopuncture
|
|
Pain at 1 min
Délai: 1 min after veinopincture
|
Measure of pain by DAN scale 1 minute after veinopuncture
|
1 min after veinopincture
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Francesco BONSANTE, MD, CHU de la Réunion
- Chercheur principal: Silvia IACOBELLI, MD, CHU de la Réunion
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2015/CHU/08
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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