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

NCT02803723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-02-11

No results posted yet for this study

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.

Conditions

  • Blood Sampling

Interventions

PROCEDURE

Holding-cuddling

The "Holding-cuddling" is started 5 minutes before veinipuncture.

PROCEDURE

Sucrose

The sucrose adminstration is started 2 minutes before veinipuncture.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Principal Investigators

  • Francesco BONSANTE, MD · CHU de La Réunion

  • Silvia IACOBELLI, MD · CHU de La Réunion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-06-30
Completion
2018-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02803723 on ClinicalTrials.gov