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Preterm and acutely ill term neonates who are hospitalized in a neonatal intensive care unit are subjected to multiple frequent invasive and painful procedures aimed at improving their outcome. Although several trials to determine the efficacy of sucrose for managing procedural pain in preterm and acutely ill term neonates have been developed, these have generally lacked methodological rigor and have not provided clinicians with clear practice guidelines.To compare the efficacy and safety of three interventions for relieving procedural pain associated with heel lances in preterm and term neonates, and to explore the influence of contextual factors including sex, severity of illness, and prior painful procedures on pain responses.In a randomized controlled trial, 190 neonates were stratified by gestational age and then randomized to receive (a) sucrose and nonnutritive sucking (n = 64), (b) sucrose alone (n = 62), or (c) sterile water and nonnutritive sucking (control) (n = 64) to evaluate the efficacy (pain response as measured using the Premature Infant Pain Profile) (Stevens, Johnson, Petryshen, & Taddio, 1996) and safety (adverse events) following a scheduled heel lance during the first week of life. Stratification was used to control for the effects of age on pain response.Significant differences in pain response existed among treatment groups (F = 22.49, p < .001), with the lowest mean Premature Infant Pain Profile scores in the sucrose and nonnutritive sucking group. Efficacy of sucrose following a heel lance was not affected by severity of illness, postnatal age, or number of painful procedures. Intervention group and sex explained 12% of the variance in Premature Infant Pain Profile scores. Few adverse events occurred (n = 6), and none of them required medical or nursing interventionsThe combination of sucrose and nonnutritive sucking is the most efficacious intervention for single heel lances. Research on the effects of gestational age on the efficacy and safety of repeated doses of sucrose is required.