Stevens 1999.
Methods | Randomized, cross‐over, controlled trial Painful intervention: heel lance Study location: NICUs of 3 metropolitan university‐affiliated teaching hospitals and 1 children's hospital in Canada and the USA Study period: a 15‐month period (dates not given) |
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Participants | 122 preterm neonates, 27 to 31 weeks' PMA, < 28 days old | |
Interventions | Each infant received all 4 interventions in a random order (serving as his/her own control); there was 1 control intervention and 3 treatment interventions
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Outcomes | PIPP | |
Notes | Repeated measures ANOVA and ANCOVA used to evaluate efficacy of treatment interventions
Means and SDs provided for pain scores prior to cross‐over for sucrose + pacifier and water + pacifier
Adverse effects were evaluated The first author provided us with unpublished information regarding the study methods. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated sequence |
Allocation concealment (selection bias) | Low risk | Allocation was enclosed in sealed, opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | The study solutions were prepared in each of the study units by the Pharmacist and labelled as Study Solution 1 and 2. The research nurses (who performed the heel lance and administered each intervention) drew up the solution specified in the intervention sequence from a dark coloured bottle, so were blind to which solution (e.g. water or 24% sucrose) was used. Nurses were not blind to the prone positioning or control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study nurse collected all of the data (e.g. videotaped facial expressions, recorded cry) and was blind to study solutions; the data coders were also blinded to which study solution was used ‐ but NOT to the prone positioning or control, as they could visualize this on the videotapes. The data analysts were blinded to all of the interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all randomized infants |
Selective reporting (reporting bias) | Low risk | The primary author assured us that there were no deviations from the protocol |
Other bias | Low risk | Appears free of other bias |