Rush 2005.
Methods | Prospective RCT Painful intervention: screening for ROP Study location: NICU at a university‐affiliated hospital, Amarillo, Texas, USA Study period: not stated |
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Participants | 30 infants < 32 weeks' GA or weighing < 1500 g Sucrose group mean GA 29.57 weeks (range 26 to 32) Control group mean GA 28.8 weeks (range 25 to 31) |
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Interventions | Sucrose group: swaddled in a warm blanket, pacifier packed with gauze soaked in 24% sucrose and held by a nurse until 15 min after the eye examination Control: no swaddling, no sucrose and not held by nurse All infants received eye drop instillation of 0.5% proxymetacaine and 1% tropicamide, then 15 min later eye drop instillation of 0.5% tropicamide and 2.5% phenylephrine All eye drops were instilled into both infant's eyes before the ROP examination |
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Outcomes | Pulse rate, respiratory rate and oxygen saturation at baseline (30 min before instillation of proxymetacaine), 5 min before eye examination, 3 different times during eye examination and 5 min after the completion of the examination; total crying time; time required to return to baseline value | |
Notes | ANOVA and Wilcoxon signed rank test and the Pearson test were used to evaluate outcomes Results were reported as medians, means and standard errors of the means (SEM). P values were also reported 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) | Unclear risk | Allocation concealment not described |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding to interventions |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessments blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Pulse rate, respiratory rate data not reported |
Selective reporting (reporting bias) | Unclear risk | Pulse rate, respiratory rate data not reported |
Other bias | Low risk | Appears free of other bias |