Trial of Repeated Analgesia With Kangaroo Care

Pain Clinical Trial

— TRAKC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561547
• Other study ID #: TRAKC
• Secondary ID: CIHR-NSHRF-Mayda
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2012
• Last updated: September 17, 2016
• Start date: June 2012
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Development
• Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	IWKHealthC	Halifax	Nova Scotia

Sponsors (4)

Lead Sponsor	Collaborator
IWK Health Centre	Canadian Institutes of Health Research (CIHR), Mayday Fund, Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130. — View Citation

Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley GA, Walker CD. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. BMC Pediatr. 2008 Apr 24;8:13. doi: 10.1186/1471-2431-8-13. — View Citation

Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. — View Citation

Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. — View Citation

Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;1:CD001069. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Infant Pain Profile (PIPP)	The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.	At the moment of painful procedure	No
Secondary	Neurobehavioral Assessment of Preterm Infants (NAPI)	Two scales of the NAPI will be scored by person blinded to the intervention. These are 1) Motor Development and Vigour and 2) Alertness and Orientation	32, 36 and 40 weeks gestational age	No