Holding-cuddling Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants

Study Overview
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Brief Summary
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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.

Official Title
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Holding-cuddling Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants

Conditions
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Blood Sampling

Intervention / Treatment
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* Procedure: Holding-cuddling
* Procedure: Sucrose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Holding-cuddling + Sucrose<br>The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling. | Procedure: Holding-cuddling<br>* The Holding-cuddling is started 5 minutes before veinipuncture.<br>Procedure: Sucrose<br>* The sucrose adminstration is started 2 minutes before veinipuncture.<br>|
| Active Comparator: Sucrose alone<br>The sucrose administration is started 2 minutes before blood sampling. | Procedure: Sucrose<br>* The sucrose adminstration is started 2 minutes before veinipuncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Pain | Measure of pain by DAN scale at the time of the veinopuncture | At 0 and 30 seconds after the veinopuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Frequency | Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after | At 0 and 30 seconds after veinopuncture | 
| Oxygen saturation | 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 | Measure of pain by DAN scale 1 minute after veinopuncture | 1 min after veinopincture |