Abstract
BackgroundOrally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure.MethodsA total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups.ResultsThere was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention.ConclusionsThe minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted.Trial registrationClinicalTrials.gov: NCT02134873. Date: May 5, 2014 (retrospectively registered).
Highlights
Administered sucrose is effective and safe in reducing pain intensity during single, tissuedamaging procedures in neonates, and is commonly recommended in neonatal pain guidelines
We evaluated the three smallest doses of sucrose most commonly reported to be effective in previous research (i.e., 0.1 ml, 0.5 ml, and 1.0 ml of 24% sucrose) [2] to determine the minimally effective dose for neonates undergoing a skin-breaking heel lance procedure while in the neonatal intensive care unit (NICU)
We noted a discrepancy between the number of painful procedures documented and the number of sucrose doses documented since birth
Summary
Administered sucrose is effective and safe in reducing pain intensity during single, tissuedamaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure. Multiple trials and recent systematic reviews with metaanalyses have shown that sweet solutions, including orally administered sucrose, are effective and safe in reducing pain intensity (using clinical observational or composite measures) during single, tissue-damaging procedures in neonates [1, 2]. These solutions are commonly recommended in neonatal pain guidelines [3]. We hypothesized that (a) there was no difference in pain intensity between the sucrose doses, measured at 30 and 60 s following the heel lance using the Premature Infant Pain Profile-Revised (PIPP-R), and (b) adverse events would be minimal
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