Trial of Repeated Analgesia With Kangaroo Care

Summary

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.

Conditions

• Pain
• Development

Interventions

BEHAVIORAL

Kangaroo Mother Care

Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.

DIETARY_SUPPLEMENT

Sucrose

24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Nova Scotia Health Research Foundation

  collaborator OTHER_GOV

• Mayday Fund

  collaborator OTHER

• IWK Health Centre

  lead OTHER

Principal Investigators

• Celeste Johnston, RN, DEd · IWK Health Centre

• Marsha Campbell-Yeo, RN, NNP, PhD · IWK Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2016-03-31

Completion

2016-07-31

Countries

• Canada

Study Locations