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

Blood Sampling Clinical Trial

— Casa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803723
• Other study ID #: 2015/CHU/08
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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)

Related Conditions & MeSH terms

• Blood Sampling

Intervention

Procedure:
• Holding-cuddling
The "Holding-cuddling" is started 5 minutes before veinipuncture.
• Sucrose
The sucrose adminstration is started 2 minutes before veinipuncture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of Pain	Measure of pain by DAN scale at the time of the veinopuncture	At 0 and 30 seconds after the veinopuncture
Secondary	Cardiac Frequency	Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after	At 0 and 30 seconds after veinopuncture
Secondary	Oxygen saturation	Measure of the oxygen saturation at the time of the veinopuncture and 30 seconds after	At 0 and 30 seconds after veinopuncture
Secondary	Pain at 1 min	Measure of pain by DAN scale 1 minute after veinopuncture	1 min after veinopincture