Leng 2013.
Methods | RCT Painful intervention: heel lance Study location: Children's Hospital of Chongqing Medical University, Chongqing 400014, China Study period: not stated |
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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 |
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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 |
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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 |