Pilot Study of Sucrose to Reduce Pain in Sick Babies
Condition: Pain Due to Certain Specified Procedures
Intervention: 24% sucrose po solution; Placebo po
Intervention description: 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.; 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sucrose; Pain

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.
    

Eligibility 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)