Pilot Study of Sucrose to Reduce Pain in Sick Babies

• Status: Terminated
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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 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 or nasogastric/orogastric (NG/OG) tube insertions. The investigators hypothesize that infants who are receiving opioid analgesics will have lower pain scores during their blood tests (heel lance) or NG/OG tube insertion, when sucrose is given, compared to when water is given.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Collaborator: University of Ottawa
• Treatments: Pharmaceutical Solutions

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 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 Criteria:

• 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)