Blass 1997.
Methods | RCT Painful intervention: heel lance Study location: Tompkins Community Hospital, Ithaca, New York, USA Study period: not stated |
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Participants | 72 newborn infants (PNA 22 h to 40 h) | |
Interventions | 2 mL 12% sucrose (n = 8)
2 mL protein solution (Provimin) (n = 8)
2 mL lactose (n = 8)
2 mL dilute fat (coconut and soy oil blend) (n = 8)
2 mL concentrated fat (n = 8)
2 mL fat and lactose solution (n = 8)
2 mL Ross Special Formula (RSF ‐ artificial milk) (n = 8)
2 mL Similac (artificial milk) (n = 8) Solutions were given via syringe over a 2‐min period |
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Outcomes | Crying time (percentage of procedure time spent crying, percentage of time spent crying during 3‐min recovery period, number of infants that cried 20% or more during each recovery minute) | |
Notes | Sucrose vs. water, Similac vs. water and RSF vs. water were compared using Mann‐Whitney U test. Most results were presented in graph form and means were reported in the text and could not be combined in meta‐analyses Adverse events 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 | Similac group could not be concealed because appearance differed from other intervention solutions |
Blinding (performance bias and detection bias) All outcomes | Low risk | Sucrose and water solutions blinded However, Similac group was high risk as its appearance differed from sucrose or water |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Sucrose and water solutions blinded. However, Similac group was high risk as its appearance differed from sucrose or water |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all randomized infants |
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 | Unclear risk | Several test solutions were gifts from Ross Laboratories |