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