Kabataş 2016.
Methods | Randomised controlled trial. Study location: tertiary level neonatal intensive care unit (NICU) of Dr. Sami Ulus Maternity and Children Research and Training Hospital, Ankara, Turkey. Study period: January 2013 to June 2014 inclusive | |
Participants | Very low birth weight (VLBW) infants (< 1500 g) who were candidates for ROP screening (n = 114) | |
Interventions | Topical anaesthetic (Proparacaine; Alcaine® drop 0.5 %) was applied 30 seconds before the eye examination in all the infants Oral paracetamol 15 mg/kg (n = 58) or oral placebo (sterile water) (n = 56) |
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Outcomes | PIPP score during examination (median IQR) Crying time (seconds) (mean and SD) |
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Notes | PIPP score during examination were presented as medians and IQRs. We transformed the data to means and SDs using the formulas presented by Wan 2014 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based randomisation process |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Either paracetamol or sterile water was provided by the pharmacy in opaque syringes. The nurse administered the solutions 60 minutes before the onset of the examination. The parents, the ophthalmologist and investigators were blinded to the randomisation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The parents, the ophthalmologist and investigators were blinded to the randomisation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised infants were accounted for |
Selective reporting (reporting bias) | Unclear risk | The protocol for the study was not available to us so we cannot judge if there were any deviations between the protocol and the report |
Other bias | Low risk | Appears free of other bias |