Status:
TERMINATED
Pilot Study of Sucrose to Reduce Pain in Sick Babies
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborating Sponsors:
University of Ottawa
Conditions:
Pain Due to Certain Specified Procedures
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 cont...
Detailed Description
Background: Sick infants nursed in Neonatal Intensive Care Units (NICU) are exposed to large numbers of repeated painful procedures during their hospitalization \[1-6\]. Effectively reducing pain duri...
Eligibility Criteria
Inclusion
- 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 and;
- Who require heel lance for medically required blood sampling or nasogastric/orogastric (NG/OG) tube insertions and;
- Who are eligible to receive sucrose as per the hospital's Sucrose policy for infants.
Exclusion
- Infants less than 25 weeks gestation
- Infants with any injury to the skin where the probe needs to be placed
- Infants with an implanted defibrillator or pacemaker
- Infants with an injury affecting sympathetic nerve conduction
- 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)
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01438008
Start Date
May 1 2012
End Date
September 1 2016
Last Update
October 19 2020
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1