"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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: Sucrose alone
The sucrose administration is started 2 minutes before blood sampling.
|
The sucrose adminstration is started 2 minutes before veinipuncture.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evolution of Pain
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiac Frequency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 min after veinopincture
|
Measure of pain by DAN scale 1 minute after veinopuncture
|
1 min after veinopincture
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Francesco BONSANTE, MD, CHU de la Réunion
- Hovedetterforsker: Silvia IACOBELLI, MD, CHU de la Réunion
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2015/CHU/08
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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