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Clinical Trials/NCT02803723
NCT02803723
Completed
Not Applicable

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

Centre Hospitalier Universitaire de la Réunion0 sites68 target enrollmentJune 2016
ConditionsBlood Sampling

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Sampling
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
68
Primary Endpoint
Evolution of Pain
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Evolution of Pain

Time Frame: At 0 and 30 seconds after the veinopuncture

Measure of pain by DAN scale at the time of the veinopuncture

Secondary Outcomes

  • Pain at 1 min(1 min after veinopincture)
  • Cardiac Frequency(At 0 and 30 seconds after veinopuncture)
  • Oxygen saturation(At 0 and 30 seconds after veinopuncture)

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