Ramenghi 1999.
Methods | Randomized, double‐blind, placebo‐controlled, cross‐over trial for the mode of delivery of sucrose or water by mouth or intragastrically Painful intervention: heel lance Study location: Leeds General Infirmary, Leeds, UK Study period: Dates not provided |
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Participants | 30 preterm infants (PMA 32 to 36 weeks, PNA < 24 h) | |
Interventions | Each infant received either sucrose or water and was not crossed over for the solution received, only for the method of delivery Sucrose group (n = 15): 25% sucrose solution (volume not reported) given via syringe into the mouth or via NG tube 2 min prior to first heel lance, and via the alternate route for the second heel lance within 48 h Water group (n = 15) : sterile water via syringe into the mouth or via NG tube 2 min prior to first heel lance and via the alternate route for the second heel lance within 48 h Cross‐over design |
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Outcomes | Percentage crying over 5 min after sampling, behavioural scores (4 facial expressions and the presence of cry) at 1, 3 and 5 min after the lance for a total behavioural score | |
Notes | Mann Whitney‐U and Wilcoxon matched pairs signed ranked test used to evaluate outcomes Results reported as median and IQR and total range 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 | Unclear risk | Did not describe measures taken to ensure blinding of intervention and outcome assessment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Did not describe measures taken to ensure blinding of intervention and outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported on 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 | Low risk | Appears free of other bias |