Blood Sampling
Conditions
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.
Interventions
PROCEDUREHolding-cuddling
The Holding-cuddling is started 5 minutes before veinipuncture.
PROCEDURESucrose
The sucrose adminstration is started 2 minutes before veinipuncture.
Sponsors
Centre Hospitalier Universitaire de la Réunion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Pain | At 0 and 30 seconds after the veinopuncture | Measure of pain by DAN scale at the time of the veinopuncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Frequency | At 0 and 30 seconds after veinopuncture | Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after |
| Oxygen saturation | At 0 and 30 seconds after veinopuncture | Measure of the oxygen saturation at the time of the veinopuncture and 30 seconds after |
| Pain at 1 min | 1 min after veinopincture | Measure of pain by DAN scale 1 minute after veinopuncture |
Outcome results
None listed