Trial Outcomes & Findings for Pilot Study of Sucrose to Reduce Pain in Sick Babies (NCT NCT01438008)

Last Updated: 2020-10-19

Results Overview

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 Facial expression scores were also recorded on a 0-4 scale using a modified Neonatal Facial Coding System (NFCS) at 30, and 60 seconds following the beginning of the procedure. The modified NFCS coded for the presence (1) or absence (0) of the 4 most common facial expressions in response to acute pain (brow bulge, eye squeeze, nasolabial furrow, and stretch open mouth). High values on both of these scales represent worse outcome (i.e higher pain intensity).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

Baseline, day one of blood test

Results posted on

2020-10-19

Participant Flow

Between June 2012 and September 2015, 73 infants admitted in the NICU were assessed for eligibility, 50 (69%) were ineligible, of the 23 (32%) infants that were approached, 7 (3%) declined to participate, 16 (70%) provided consent.

Consent was obtain for 16 infants to participate, 7 (44%) were not randomized (prior to data collection n=3 infants were weaned off fentanyl, n=3 infants were discharged/transferred, n=1 medical team refused). 9 (12%) infants were randomized. 4 infants were allocated to sucrose and 5 infants were allocated to water.

Participant milestones

Participant milestones
Measure	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 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.	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 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
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Sucrose to Reduce Pain in Sick Babies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sucrose 24% po n=4 Participants 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 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.	Placebo po n=5 Participants 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 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	Total n=9 Participants Total of all reporting groups
Type of Procedure Naso/oro gastric insertion	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Duration of Procedure	281 seconds n=93 Participants	380 seconds n=4 Participants	301 seconds n=27 Participants
Type of opioid administered Morphine	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Type of opioid administered Fentanyl	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Previous use of sucrose Yes	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Age, Continuous	261.5 gestational age (days) n=93 Participants	236.0 gestational age (days) n=4 Participants	236.0 gestational age (days) n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Type of Procedure Heel lance	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Previous use of sucrose No	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Previous use of sucrose Unknown	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, day one of blood test

Outcome measures

Outcome measures
Measure	Sucrose 24% po n=4 Participants 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 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.	Placebo po n=5 Participants 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 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
Premature Infant Pain Profile (PIPP) NFCS at 60 seconds	2 score on a scale Interval 0.0 to 4.0	0 score on a scale Interval 0.0 to 3.0
Premature Infant Pain Profile (PIPP) PIPP-R at 30 seconds	9.5 score on a scale Interval 7.5 to 13.75	10 score on a scale Interval 3.5 to 11.5
Premature Infant Pain Profile (PIPP) PIPP-R at 60 seconds	9.5 score on a scale Interval 6.25 to 14.25	9 score on a scale Interval 4.0 to 14.0
Premature Infant Pain Profile (PIPP) NFCS at 30 seconds	1.5 score on a scale Interval 0.25 to 3.5	0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Total crying time were recorded as a proportion of the time spent crying over the total length of procedure and/or in the 3 minutes that followed.

Cry duration is a useful method to determine infant distress in general and to evaluate pain in the infant's environmental context.

Outcome measures

Outcome measures
Measure	Sucrose 24% po n=4 Participants 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 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.	Placebo po n=5 Participants 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 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
Total Crying Time	0 seconds Interval 0.0 to 147.1275	0 seconds Interval 0.0 to 102.685

Adverse Events

Sucrose 24% po

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo po

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Denise Harrison

Children's Hospital of Eastern Ontario

Phone: 6137377600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place