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. 2020 Jan 27;2020(1):CD011219. doi: 10.1002/14651858.CD011219.pub4

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)
Outcomes PIPP score during examination (median IQR)
Crying time (seconds) (mean and SD)
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