Clinical trial NCT02803723: "Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants
Official title: "Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sampling
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 68
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: "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.


Eligibility criteria: 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)

Primary outcomes:
measure: Evolution of Pain
timeFrame: At 0 and 30 seconds after the veinopuncture
Secondary outcomes:
measure: Cardiac Frequency
timeFrame: At 0 and 30 seconds after veinopuncture
measure: Oxygen saturation
timeFrame: At 0 and 30 seconds after veinopuncture
measure: Pain at 1 min
timeFrame: 1 min after veinopincture
Other outcomes:
Locations:
Study officials:
affiliation: CHU de La Réunion
name: Francesco BONSANTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de La Réunion
name: Silvia IACOBELLI, MD
role: PRINCIPAL_INVESTIGATOR
References: