Pilot Study of Sucrose to Reduce Pain in Sick Babies
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.
Pain Due to Certain Specified Procedures
Drug: 24% sucrose po solution
Drug: Placebo po
|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|
- 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
- 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.
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438008
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Denise Harrison, PhD||Children's Hospital of Eastern Ontario|