NCT01561547

Trial of Repeated Analgesia With Kangaroo Care

Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-03-01
• Completion: 2016-07-01
• First posted: 2012-03-23
• Last updated: 2016-09-20

Locations

1 site across 1 country: Canada