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

"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.

Study Overview

• Status: Completed
• Conditions: Blood Sampling
• Intervention / Treatment: Procedure: Holding-cuddling; Procedure: Sucrose

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Francesco BONSANTE, MD, CHU de la Réunion; Principal Investigator: Silvia IACOBELLI, MD, CHU de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015/CHU/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO