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) |
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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 |