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Completed

NCT Number: NCT02803723

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

"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.

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Key information

Conditions

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Holding-cuddling

Procedure

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

Sucrose

Procedure

The sucrose adminstration is started 2 minutes before veinipuncture.

Primary outcomes

  1. 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

  1. Cardiac Frequency

    Time frame: At 0 and 30 seconds after veinopuncture

    Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after

  2. Oxygen saturation

    Time frame: At 0 and 30 seconds after veinopuncture

    Measure of the oxygen saturation at the time of the veinopuncture and 30 seconds after

  3. Pain at 1 min

    Time frame: 1 min after veinopincture

    Measure of pain by DAN scale 1 minute after veinopuncture

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: Casa

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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