Mitchell 2004.

Methods	Randomized, double‐blind, placebo‐controlled trial Painful intervention: screening for ROP Study location: level‐3 university‐affiliated NICU, Monroe, Louisiana, USA Study period: February 2002 to August 2002
Participants	30 preterm infants Sucrose group: mean PMA 26.5 weeks, mean PNA 8.5 weeks Water group: mean PMA 27.3 weeks, mean PNA 8.2 weeks
Interventions	Sucrose group (n = 15): pacifier and 3 doses of 0.1 mL 24% sucrose drops Water group (n = 15): pacifier and 3 doses of 0.1 mL sterile water drops Both groups received proxymetacaine hydrochloride 0.5% and were swaddled before the eye examination
Outcomes	PIPP at baseline; at eye drops instillation; during examination of left eye and at 30 s, 60 s, 90 s and 120 s after completion of the eye examination
Notes	Results were in graph form and reported as means and standard errors of the means. A series of t‐tests were conducted and their P values reported Adverse events were not evaluated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization sequence
Allocation concealment (selection bias)	High risk	Allocated using sealed envelopes, but did not specify whether envelopes were opaque or sequentially numbered
Blinding (performance bias and detection bias) All outcomes	Low risk	Sucrose and water solutions administered blinded to staff Nurse administering interventions was aware of group allocation. All other personnel and investigators were blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessment was 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