Pilot Study of Sucrose to Reduce Pain in Sick Babies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Ottawa
Information provided by (Responsible Party):
Denise Harrison, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01438008
First received: September 16, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests and injections. The investigators do not know if sugar also reduces pain in babies already receiving a continuous infusion of opioid analgesics. This project will help determine if small amounts of sugar water reduce pain in babies already receiving a continuous infusion of opioid analgesic during a heel lance procedure. The investigators hypothesize that infants who are receiving opioid analgesics will have lower pain scores during their blood tests (heel lance), when sucrose is given, compared to when water is given.


Condition Intervention Phase
Pain Due to Certain Specified Procedures
Drug: 24% sucrose po solution
Drug: Placebo po
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Be Sweet to Sick Babies: Analgesic Effects of Oral Sucrose and Concomitant Opioid Analgesics; a Pilot Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Premature Infant Pain Profile (PIPP) [ Time Frame: Baseline, day one of blood test ] [ Designated as safety issue: No ]
    The Premature Infant Pain Profile (PIPP), a validated seven-indicator multidimensional pain assessment tool which is extensively used in neonatal pain research. The scale consists of seven indicators including assessment of gestational age and behavioural state (contextual indicators), heart rate and oxygen saturation (physiological indicators), and facial actions—brow bulge, eye squeeze, and nasolabial furrow (behavioural indicators), which are scored on a 0-3 scale and added for a total score of 0-21


Secondary Outcome Measures:
  • Total crying time [ Time Frame: Total crying time will be measured during, and in the 3 minutes following completion of the heel lance procedure ] [ Designated as safety issue: No ]
    Cry duration is a useful method to determine infant distress in general and to evaluate pain in the infant's environmental context.

  • Skin conductance activity [ Time Frame: Skin conductance activity will be measured continuously throughout the procedure, from the beginning of delivery of intervention 2 minutes prior to heel lance, until 3 minutes following completion of procedure. ] [ Designated as safety issue: No ]
    Skin conductance activity is considered to be a valid, non-invasive, physiological measure of pain and stress in both preterm and term infants which is unaffected by environmental temperature or by physiological status. Skin conductance will be obtained by measuring frequency (Hz) of skin conductance responses, measured as the number of skin conductance waves per second.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sucrose 24% po
24% sucrose solution. The CHEO pharmacy department will provide syringes labeled "NICU Pain Relief Study" containing a maximum dose of 1 mL of a 24% sucrose solution
Drug: 24% sucrose po solution
CHEO pharmacy department will provide syringes labeled "NICU Pain Relief Study" containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure.
Other Name: CHEO Sucrose
Placebo Comparator: Placebo po
The CHEO pharmacy department will provide a syringe labeled "NICU Pain Relief Study" containing a maximum of 1 ml dose of water (contents almost identical in color, consistency and odor to the sucrose solution) in identical packagings
Drug: Placebo po
CHEO pharmacy department will provide syringes labeled "NICU Pain Relief Study" containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure
Other Name: Baxter sterile water

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Infants who are inpatients of the NICU:

  • Who are receiving a continuous intravenous infusion of an opioid analgesic such as morphine or fentanyl at a maximum dose equivalent to 20 mcg/kg/hr of morphine following either abdominal (gastrointestinal or renal) or thoracic surgery and;
  • Who require heel lance for medically required blood sampling, and;
  • Who are eligible to receive sucrose as per the hospital's Sucrose policy for infants.

Exclusion Criteria:

  • Infants exposed to antenatal methadone
  • Infants who, aside from being on opioid analgesics, are ineligible to receive sucrose as per the hospital's Sucrose policy38
  • If the infant's mother wishes to breastfeed during the procedure
  • Infants with known or suspected fructose intolerance
  • Infants with spinal cord malformation (e.g. myelomeningocele and sacral teratoma) since these infant's response, and sensitivity to pain may differ from infants without spinal cord malformations
  • Infants who are unconscious, heavily sedated and those with absent gag and/or swallow reflex
  • Infants who are in isolation with only essential personnel caring for them
  • To ensure there is no interaction effect of muscle relaxants, which may impact on infants' ability to mount a behavioural response to pain, assessments will not be conducted until a period of 24 hours since the previous muscle relaxant dose.
  • Parental language barrier (if unable to speak/understand French and/or English)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438008

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
University of Ottawa
Investigators
Principal Investigator: Denise Harrison, PhD Children's Hospital of Eastern Ontario
  More Information

Publications:
Porter FL, Anand KJ. Epidemiology of Pain in Neonates. Research & Clinical Forums 20(4): 9-16, 1998.

Responsible Party: Denise Harrison, Endowed Chair in Nursing Care of Children, Youth and Families, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01438008     History of Changes
Other Study ID Numbers: 123942
Study First Received: September 16, 2011
Last Updated: January 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
Sucrose
Pain

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014