PEDIATRICS Vol. 109 No. 6 June 2002, pp. 1093-1099
A Clinical Study to Evaluate the Efficacy of ELA-Max (4% Liposomal Lidocaine) as Compared With Eutectic Mixture of Local Anesthetics Cream for Pain Reduction of Venipuncture in Children
From the Division of Pediatric and Adolescent Dermatology, Children’s Hospital, San Diego, and Departments of Pediatrics and Medicine, University of California, San Diego School of Medicine, San Diego, California
--> Objective. A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations.
Methods. A total of 120 children who were scheduled for repeat venipuncture for non–study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child’s rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent’s and blinded research observer’s Observed Behavioral Distress scores.
Results. Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress."
Conclusion. This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.
Key Words: topical anesthesia • liposomal lidocaine • pain • eutectic mixture of local anesthetics
Abbreviations: EMLA, eutectic mixture of local anesthetics • VAS, visual analog scale • OBD, Observed Behavioral Distress • SD, standard deviation
Received for publication Aug 15, 2001; Accepted .
CiteULike 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
This article has been cited by other articles:
|
|
 |
|
  B. A. Howell and A. Chauhan Bupivacaine Binding to Pegylated Liposomes Anesth. Analg., August 1, 2009; 109(2): 678 - 682. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 W. T. Zempsky Pharmacologic Approaches for Reducing Venous Access Pain in Children Pediatrics, November 1, 2008; 122(Supplement_3): S140 - S153. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. Leahy, R. M. Kennedy, J. Hesselgrave, K. Gurwitch, M. Barkey, and T. F. Millar On the Front Lines: Lessons Learned in Implementing Multidisciplinary Peripheral Venous Access Pain-Management Programs in Pediatric Hospitals Pediatrics, November 1, 2008; 122(Supplement_3): S161 - S170. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. Pershad, S. C. Steinberg, and T. M. Waters Cost-effectiveness Analysis of Anesthetic Agents During Peripheral Intravenous Cannulation in the Pediatric Emergency Department Arch Pediatr Adolesc Med, October 1, 2008; 162(10): 952 - 961. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. T. Zempsky, J. Bean-Lijewski, R. E. Kauffman, J. L. Koh, S. V. Malviya, J. B. Rose, P. T. Richards, and D. J. Gennevois Needle-Free Powder Lidocaine Delivery System Provides Rapid Effective Analgesia for Venipuncture or Cannulation Pain in Children: Randomized, Double-Blind Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment Trial Pediatrics, May 1, 2008; 121(5): 979 - 987. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Cregin, A. S Rappaport, G. Montagnino, G. Sabogal, H. Moreau, and J. J. Abularrage Improving pain management for pediatric patients undergoing nonurgent painful procedures Am. J. Health Syst. Pharm., April 15, 2008; 65(8): 723 - 727. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Franz-Montan, A. L. R. Silva, K. Cogo, C. d. C. Bergamaschi, M. C. Volpato, J. Ranali, E. de Paula, and F. C. Groppo Liposome-Encapsulated Ropivacaine for Topical Anesthesia of Human Oral Mucosa Anesth. Analg., June 1, 2007; 104(6): 1528 - 1531. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. L. Schechter, W. T. Zempsky, L. L. Cohen, P. J. McGrath, C. M. McMurtry, and N. S. Bright Pain Reduction During Pediatric Immunizations: Evidence-Based Review and Recommendations Pediatrics, May 1, 2007; 119(5): e1184 - e1198. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
American Academy of Pediatrics, American Academy of Pediatric Dentistry, C. J. Cote, S. Wilson, and the Work Group on Sedation Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures: An Update Pediatrics, December 1, 2006; 118(6): 2587 - 2602. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C V Bellieni, D M Cordelli, M Raffaelli, B Ricci, G Morgese, and G Buonocore Analgesic effect of watching TV during venipuncture Arch. Dis. Child., December 1, 2006; 91(12): 1015 - 1017. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. J. Sharek, R. Powers, A. Koehn, and K. J.S. Anand Evaluation and Development of Potentially Better Practices to Improve Pain Management of Neonates Pediatrics, November 1, 2006; 118(Supplement_2): S78 - S86. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. V. Fernandez and G. Frager Reducing procedural pain Can. Med. Assoc. J., January 17, 2006; 174(2): 206 - 206. [Full Text] [PDF]
|
|
|
|
|
|
A. Taddio, H. K. Soin, S. Schuh, G. Koren, and D. Scolnik Liposomal lidocaine to improve procedural success rates and reduce procedural pain among children: a randomized controlled trial Can. Med. Assoc. J., June 21, 2005; 172(13): 1691 - 1695. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Migdal, E. Chudzynska-Pomianowska, E. Vause, E. Henry, and J. Lazar Rapid, Needle-Free Delivery of Lidocaine for Reducing the Pain of Venipuncture Among Pediatric Subjects Pediatrics, April 1, 2005; 115(4): e393 - e398. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 O Quaba, J S Huntley, H Bahia, and D W McKeown A users guide for reducing the pain of local anaesthetic administration Emerg. Med. J., March 1, 2005; 22(3): 188 - 189. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. T. Zempsky, J. P. Cravero, and Committee on Pediatric Emergency Medicine, and Sec Relief of Pain and Anxiety in Pediatric Patients in Emergency Medical Systems Pediatrics, November 1, 2004; 114(5): 1348 - 1356. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. S. Houck Taking `ouch' out of doctor visits easier than ever AAP News, August 1, 2004; 25(2): 66 - 66. [Full Text] [PDF]
|
|
|
|
 |
|
 L. Hefler, C. Grimm, S. Leodolter, and C. Tempfer To Butterfly or To Needle: The Pilot Phase Ann Intern Med, June 1, 2004; 140(11): 935 - 936. [Full Text] [PDF]
|
|
|
|
 |
|
 R. D Goldman ELA-max: A New Topical Lidocaine Formulation Ann. Pharmacother., May 1, 2004; 38(5): 892 - 894. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Luhmann, S. Hurt, M. Shootman, and R. Kennedy A Comparison of Buffered Lidocaine Versus ELA-Max Before Peripheral Intravenous Catheter Insertions in Children Pediatrics, March 1, 2004; 113(3): e217 - 220. [Abstract] [Full Text] [PDF]
|
|
