Boyle 2006.
Methods | RCT Painful intervention: screening for ROP Study location: Neonatal Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland, UK and Neonatal Unit, Birmingham Heartlands Hospital, Birmingham, UK Study period: not stated |
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Participants | 40 preterm infants < 32 weeks' PMA Sterile water group: mean PMA 27 weeks; mean PNA 45 days Sucrose group: mean PMA 29 weeks; mean PNA 43 days Water + pacifier group: mean PMA 30 weeks; mean PNA 41 days Sucrose + pacifier group: mean PMA 29 weeks; mean PNA 42 days |
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Interventions | 2 min before start of eye examination: 1 mL sterile water (n = 10) 1 mL sucrose 33% (n = 10) 1 mL sterile water + pacifier (n = 9) 1 mL sucrose 33% + pacifier (n = 11) Water or sucrose was given by mouth using a syringe | |
Outcomes | PIPP during eye examination | |
Notes | Data were presented in graph form and reported as means and SDs
Results of ANOVA and independent t‐tests reported as P values Adverse events were not evaluated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described |
Allocation concealment (selection bias) | High risk | Sealed opaque envelopes. Did not state if the envelopes were sealed and sequentially numbered |
Blinding (performance bias and detection bias) All outcomes | Low risk | Sucrose and water alone groups blinded; pacifier + water, and pacifier + sucrose groups were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Sucrose and water alone groups blinded; pacifier + water, and pacifier + sucrose groups were blinded |
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 | Low risk | Appears free of other bias |