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. 2016 Jul 15;2016(7):CD001069. doi: 10.1002/14651858.CD001069.pub5

Overgaard 1999.

Methods Double‐blind RCT
Painful intervention: heel lance
Study location: Department of Obstetrics and Gynaecology, Aalborg University Hospital, Aalborg, Denmark
Study period: 3 months (dates not provided)
Participants 100 newborn term infants, mean age 6 days (range 4 to 9)
Interventions 2 mL 50% sucrose solution via syringe into the mouth over 30 s, 2 min prior to heel lance (n = 50)
 2 mL sterile water via syringe into the mouth over 30 s, 2 min prior to heel lance (n = 50)
Outcomes NIPS score, crying time (duration of first cry, crying time during heel lance, fraction of crying during sampling, crying time during first minute after end of sampling, total crying time), NIPS 1 min after heel lance and 1 min after blood sampling, change in HR at 0 min and 1 min, change in oxygen saturation at 0 min and 1 min
Notes Results were reported as medians and 5% and 95% percentiles ‐ we did not attempt to convert to means and SDs. Four infants were excluded after randomisation due to failure of the videotaping leaving 96 newborns for analysis; sucrose n = 49; placebo n = 47
 Statistical testing used Mann Whitney U and Fisher's exact test
 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) Low risk 100 syringes manufactured at random to contain sucrose or water. Numbered and administered consecutively. Contents were unknown to investigators and parents
Blinding (performance bias and detection bias) 
 All outcomes Low risk Sucrose and water solutions were administered blinded to investigators and parents
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of outcome assessments
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 4 infants were excluded due to failure of videotaping, leaving 96 newborns for analysis
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