Summary of findings for the main comparison. EMLA compared with placebo for needle‐related pain in newborn infants.

EMLA compared with placebo for needle‐related pain in newborn infants
Patient or population: preterm infants Settings: NICU Intervention: EMLA Comparison: placebo
Outcomes	Anticipated absolute effects (95% CI)		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with placebo	Risk with EMLA
Pain using PIPP score	The mean pain using PIPP score was 0	MD 0.27 higher (1.45 lower to 1.99 higher)	‐	38 (1 study)	⊕⊕⊝⊝ Low	Single study
Pain using NIPS score	The mean pain using NIPS score was 0	MD 0.27 higher (0.75 lower to 1.29 higher)	‐	38 (1 study)	⊕⊕⊝⊝ Low	Single study
Successful venepuncture first attempt	Study population		RR 0.98 (0.93 to 1.03)	111 (1 study)	⊕⊕⊝⊝ Low	Single study
	1000 per 1000	980 per 1000
Adverse effects (short‐lasting skin reactions)	Study population		RR 1.65 (1.24 to 2.19)	272 (3 studies)	⊕⊕⊝⊝ Low	High heterogeneity
	269 per 1000	444 per 1000
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; EMLA: eutectic mixture of local anaesthetics; MD: mean difference; NICU: neonatal intensive care unit; NIPS: Neonatal Infant Pain Scale; PIPP: Premature Infant Pain Profile; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.