Gormally 2001.
Methods | RCT, factorial design Painful intervention: heel lance Study location: Lakeshore General Hospital, Montreal, Quebec, Canada Study period: not stated |
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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 |