"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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: Sucrose alone
The sucrose administration is started 2 minutes before blood sampling.
|
The sucrose adminstration is started 2 minutes before veinipuncture.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evolution of Pain
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cardiac Frequency
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 1 min after veinopincture
|
Measure of pain by DAN scale 1 minute after veinopuncture
|
1 min after veinopincture
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Francesco BONSANTE, MD, CHU de la Réunion
- Hoofdonderzoeker: Silvia IACOBELLI, MD, CHU de la Réunion
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2015/CHU/08
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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