"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants
- Conditions
- Blood Sampling
- Interventions
- Procedure: Holding-cuddlingProcedure: Sucrose
- Registration Number
- NCT02803723
- Lead Sponsor
- Centre Hospitalier Universitaire de la Réunion
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Holding-cuddling + Sucrose Holding-cuddling The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling. Holding-cuddling + Sucrose Sucrose The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling. Sucrose alone Sucrose The sucrose administration is started 2 minutes before blood sampling.
- Primary Outcome Measures
Name Time Method Evolution of Pain At 0 and 30 seconds after the veinopuncture Measure of pain by DAN scale at the time of the veinopuncture
- Secondary Outcome Measures
Name Time Method Pain at 1 min 1 min after veinopincture Measure of pain by DAN scale 1 minute after veinopuncture
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