Trial of Repeated Analgesia With Kangaroo Care (TRAKC)

IWK Health Centre

Status and phase: Completed; Phase 3

Conditions: Development; Pain

Treatments: Behavioral: Kangaroo Mother Care; Dietary Supplement: Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT01561547

TRAKC

CIHR-NSHRF-Mayday RPP 2446 (Other Identifier)

Details and patient eligibility

About

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.

AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.

Enrollment: 242 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• less than 36.0 weeks gestational age
• mother is generally available to provide kangaroo mother care

Exclusion criteria

• narcotic analgesics
• surgery in past 48 hrs
• major congenital anomalies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 3 patient groups

Kangaroo Mother Care

Experimental group

Description:

Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sterile water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.

Treatment:

Behavioral: Kangaroo Mother Care

Sucrose

Active Comparator group

Description:

Two minutes before the painful procedure and at the moment of the procedure, the infant will be given 24% sucrose by mouth. The volume is determined by body weight and is not important in terms of efficacy, it is the percentage of sweetness that is important.

Treatment:

Dietary Supplement: Sucrose

Combination Kangaroo Mother Care and Sucrose

Experimental group

Description:

Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.

Treatment:

Dietary Supplement: Sucrose

Behavioral: Kangaroo Mother Care