O'Sullivan 2010.
Methods | Randomized, prospective, placebo‐controlled study Painful intervention: screening for ROP Study location: Dublin, Ireland Study period: not stated |
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Participants | 40 preterm infants Water group: mean PMA ± SD = 29.5 ± 2.3 weeks, mean corrected age at first eye examination ± SD = 33.1 ± 1.2 weeks Sucrose group: mean PMA ± SD = 29.8 ± 2.4 weeks, mean corrected age at first eye examination ± SD = 33.0 ± 1.1 weeks |
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Interventions | Sucrose group: 0.2 mL 24% sucrose given by mouth using a syringe and a pacifier (N = 20) Water group: 0.2 mL sterile water given by mouth using a syringe and a pacifier (N = 20) Both groups were swaddled |
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Outcomes | N‐PASS; HR and oxygen saturation at baseline; number of episodes of bradycardia, desaturation | |
Notes | Recorded number of adverse events | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based randomization process used |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque and sealed envelopes used |
Blinding (performance bias and detection bias) All outcomes | Low risk | Only pharmacist was aware of the identify of solutions, all other personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome 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 |