title: Efficacy and safety of sucrose for procedural pain relief in preterm and term neonates.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 interventions.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Faculty of Nursing, Health Scoences Center, Sunnybrook and Women's College Hospital, 76 Grenville Street, Rm 445, Toronto, Ontario, Canada M5A 1B2. sharyn.gibbins@swchsc.on.ca
authors.forename: Sharyn
authors.initials: S
authors.lastname: Gibbins
authors.forename: Bonnie
authors.initials: B
authors.lastname: Stevens
authors.forename: Ellen
authors.initials: E
authors.lastname: Hodnett
authors.forename: Janet
authors.initials: J
authors.lastname: Pinelli
authors.forename: Arne
authors.initials: A
authors.lastname: Ohlsson
authors.forename: Gerarda
authors.initials: G
authors.lastname: Darlington
mesh_terms: D000704:Analysis of Variance; D001800:Blood Specimen Collection / Q000009:adverse effects; D005260:Female; D005865:Gestational Age; D006365:Heel / Q000098:blood supply; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D017283:Neonatal Nursing / Q000379:methods; D009730:Nursing Assessment; D015403:Nursing Evaluation Research; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement / Q000379:methods; D012449:Safety; D012720:Severity of Illness Index; D013391:Sucking Behavior; D013395:Sucrose / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D013395:Sucrose