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

Leng 2013.

Methods RCT
Painful intervention: heel lance
Study location: Children's Hospital of Chongqing Medical University, Chongqing 400014, China
Study period: not stated
Participants 560 full‐term neonates (male 295, female 265)
PMA 37 to 42 weeks; weight at birth 2500 g to 4000 g; Apgar scores at 1 min and 5 min after birth averaged
Inclusion criteria: ≥ 8 points; age 3 to 28 days; had not undergone surgery; baseline HR 120‐140 beats/min; oxygen saturation ≥ 0.90; planned screening for congenital metabolic disease
Exclusion criteria: neonates presenting with asphyxia, congenital heart disease, and neuromuscular disease during birth; oxygen inhalation; hyperglycaemia; fasting; received sedative injection within last 48 h; fructose intolerance; maternal methadone dependence; vertebral injury
Interventions The infants were randomized to 7 groups:
Placebo group (plain boiled water)
10% glucose
25% glucose
50% glucose
12% sucrose
24% sucrose
30% sucrose
The solutions were administered through a syringe dripping into the neonate's mouth 2 min before heel lance
Outcomes The heel lance procedure was recorded by video. HR, oxygen saturation and pain scores were assessed at 1 min before heel lance and 3, 5 and 10 min after heel lance. Results were reported as means and full ranges.
Notes The article was translated for us by Mr David Corpman
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A table of random numbers was used
Allocation concealment (selection bias) Unclear risk A lottery method was used to assign the 7 groups to a boiled water placebo control group (placebo group), glucose groups (10%, 25%, and 50% concentration (mass concentration)), and sucrose groups (12%, 24%, and 30% concentration)
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk There was no statement that staff and assessors were blinded to intervention groups
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The heel lance procedure was recorded by video. HR, oxygen saturation and pain scores were assessed at 1 min before heel lance and 3, 5 and 10 min after the heel lance. It is not stated if the assessors were blinded to intervention groups
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Results reported for 80 infants in each group
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