"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants (Casa)

Centre Hospitalier Universitaire de la Réunion

Status: Completed

Conditions: Blood Sampling

Treatments: Procedure: Sucrose; Procedure: Holding-cuddling

Study type: Interventional

Funder types: Other

Identifiers

NCT02803723

2015/CHU/08

Details and patient eligibility

About

"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.

Enrollment: 68 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Holding-cuddling + Sucrose

Experimental group

Description:

The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling.

Treatment:

Procedure: Sucrose

Procedure: Holding-cuddling

Sucrose alone

Active Comparator group

Description:

The sucrose administration is started 2 minutes before blood sampling.

Treatment:

Procedure: Sucrose