March 17, 2011 — Sucrose is more effective than liposomal lidocaine for reducing pain during venipuncture in newborns, according to the results of a double-blind, randomized controlled, double-dummy trial study reported online March 14 in Pediatrics.
"Sucrose has been shown to reduce pain responses in infants undergoing venipuncture," write Anna Taddio, PhD, from the University of Toronto in Ontario, Canada, and colleagues. "The relative and combined effectiveness of sucrose and liposomal lidocaine, however, have not been previously evaluated."
The goal of the study was to compare the relative efficacy of liposomal lidocaine, sucrose, and their combination for decreasing pain in term newborns.
Before venipuncture for the newborn screening test, 330 healthy neonates were randomly allocated to pretreatment with 1 g of topical liposomal lidocaine cream, 2 mL of 24% sucrose solution by mouth, or sucrose and liposomal lidocaine.
Pain was evaluated with the facial grimacing score (0 - 100), and safety was determined from adverse events and lidocaine levels.
The groups did not differ in infant characteristics. Compared with the liposomal lidocaine group, the sucrose group had lower facial grimacing scores (mean difference, −27; 95% confidence interval [CI], −36 to −19; P < .001), as did the sucrose plus liposomal lidocaine group (mean difference, −23; 95% CI, −31 to −14; P < .001). There was no significant difference in the sucrose vs sucrose plus liposomal lidocaine groups (mean difference, −5; 95% CI, −13 to 4; P = .3).
There were no apparent local skin reactions. Spitting up occurred in similar proportions of sucrose-exposed and non–sucrose-exposed infants (1.4% vs 2.7%, respectively; P = .22). The mean (SD) plasma lidocaine level was 44.6 (55.3) ng/mL.
"Sucrose was more effective than liposomal lidocaine for reducing pain during venipuncture in newborns," the study authors write. "The addition of liposomal lidocaine to sucrose did not confer any additional benefit to sucrose alone. There was no evidence of harm from liposomal lidocaine or sucrose."
Limitations of this study include lack of a placebo control group, the possibility that all of the pain assessment methods used were insufficiently sensitive to detect the additive benefit of topical liposomal lidocaine, and lack of generalizability to pain relief for other medical procedures.
"Effective pain management is considered a critical aspect of quality neonatal medical care," the study authors conclude. "Notwithstanding the availability of effective agents, procedural pain remains ubiquitous and undertreated. Unanswered questions about the pharmacology of available pain-relieving interventions have been identified as a barrier to optimal pain management."
The Canadian Institutes of Health Research supported this study. Hawaii Medical provided the sucrose and placebo solutions, and Ferndale Laboratories provided the liposomal lidocaine and placebo creams. The study authors have disclosed no relevant financial relationships.
Pediatrics. Published online March 14, 2011. Abstract
A guideline on the topic of prevention and management of pain in the neonate has been jointly developed by the American Academy of Pediatrics Committee on Fetus and Newborn, the American Academy of Pediatrics Section on Surgery, and the Canadian Paediatric Society Fetus and Newborn Committee and is available online.
Venipuncture is a common painful procedure performed in neonates. Analgesic therapies used include topical liposomal lidocaine and oral sucrose solution, but the 2 methods have not been compared or combined.
This is a double-blind, randomized controlled, double-dummy study to examine the efficacy of sucrose with and without topical liposomal lidocaine vs topical lidocaine alone for pain control in infants receiving venipuncture.