Milazzo 2011.

Methods	Double‐blind, RCT Painful intervention: arterial puncture Study location: a 40‐bed, Level III, NICU of a 564‐bed community‐based hospital in midwest USA Study period: 12‐month period (Dates not reported)
Participants	47 neonates, 30 to 36 weeks’ PMA, 48 h old, nil by mouth status, and medical requirement for an arterial puncture
Interventions	Sucrose group (n = 24): 0.5 mL solution oral sucrose (Sweet‐Ease, preservative‐free, 24% sucrose solution 99044, Children’s Medical Ventures, Norwell, Massachusetts) given in a 1 mL syringe 1‐3 min before arterial puncture. A pacifier was then held in place lightly and infant's extremities swaddled by nurses assigned to infant’s care. Arterial puncture was performed by another nurse Control group (n = 23): a pacifier was held in place lightly and infant's extremities swaddled by nurses assigned to infant’s care. Arterial puncture was performed by another nurse
Outcomes	NIPS, HR, oxygen saturation (%)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random assignment to groups was done using a computer randomization scheme
Allocation concealment (selection bias)	High risk	Envelopes were sealed, but not sequentially numbered
Blinding (performance bias and detection bias) All outcomes	Low risk	Immediately prior to the therapeutically required arterial puncture, the study investigator left the infant’s room while the nurse caring for the infant opened the sealed envelope containing the randomization assignment to treatment group. Infants assigned to the sucrose solution treatment group were then given a 0.5 mL solution of oral sucrose in a 1‐mL syringe by the nurse caring for the infant. Infants assigned to the placebo group did not receive any oral solution The investigator was then called back to the infant’s bedside, remaining blinded to treatment group assignment, and obtained baseline study data (NIPS; HR; oxygen saturation) immediately after the arterial puncture needle was inserted and again 1 min after the arterial puncture procedure was completed For infants assigned to the sucrose treatment group, the time from sucrose administration to arterial puncture was at least 1 min but not more than 3 min. Group assignment codes were not revealed to study investigators until study enrolment was completed
Blinding of outcome assessment (detection bias) All outcomes	Low risk	See blinding of participants and personnel. Group assignment codes were not revealed to study investigators until study enrolment was completed
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data were presented for 47/49 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