Skip to main content
. 2016 Jul 15;2016(7):CD001069. doi: 10.1002/14651858.CD001069.pub5

Gormally 2001.

Methods RCT, factorial design
Painful intervention: heel lance
Study location: Lakeshore General Hospital, Montreal, Quebec, Canada
Study period: not stated
Participants 94 normally developing newborns, mean PMA 39.4 weeks on 2nd or 3rd day of life
 9 infants did not complete the study for the following reasons: early discharge, nurse or testing room unavailability to obtain heel lance, infant removed from study prior to start date, technical difficulties
Interventions No holding + sterile water given by pipette (n = 21)
 No holding + 0.25 mL 24% sucrose solution (0.06 g) given by pipette (n = 22)
 Holding + sterile water given by pipette (n= 20)
 Holding + 0.25 mL 24% sucrose solution (0.06 g) given by pipette (n = 22)
 All solutions given 3 times at 30‐s intervals
Outcomes Percentage of time crying, pain concatenation scores for facial activity, mean HR, mean vagal tone index, measurements prior to intervention and at 1, 2, and 3 min after heel lance
Notes Factorial ANOVA to assess effects on behavioural and physiological measures
 No means or standard deviations reported in numbers, only in graph form
 Adverse effects were not evaluated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not described
Allocation concealment (selection bias) Unclear risk Allocation concealment not described
Blinding (performance bias and detection bias) 
 All outcomes Low risk Sucrose and water solutions blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Facial coders were blind to solution assignment only but not to holding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Results reported for all infants who completed the study
Selective reporting (reporting bias) Unclear risk The study protocol was not available to us so we could not judge whether there were any deviations from it
Other bias Low risk Appears free of other bias