FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Volume 336:1197-1201 April 24, 1997 Number 17 Next

	Full Text PDF Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Neonatal circumcision is a painful surgical procedure often performed without analgesia. We assessed the efficacy and safety of 5 percent lidocaine–prilocaine cream (Emla) in neonates undergoing circumcision.

Methods We carried out a double-blind, randomized, controlled trial in 68 full-term male neonates: 38 were assigned to receive lidocaine–prilocaine cream, and 30 to receive placebo. One gram of lidocaine–prilocaine or placebo cream was applied to the penis under an occlusive dressing for 60 to 80 minutes before circumcision. Behavioral (facial activity and time spent crying) and physiologic (heart rate and blood pressure) responses were recorded during the procedure. Blood samples were obtained at various times after drug application for measurements of methemoglobin and plasma lidocaine, prilocaine, and o -toluidine (a metabolite of prilocaine).

Results A total of 68 and 59 neonates were included in the safety and efficacy analyses, respectively. Demographic characteristics such as gestational age and birth weight did not differ between the lidocaine–prilocaine and placebo groups. During circumcision, the neonates in the lidocaine–prilocaine group had less facial activity (P = 0.01), spent less time crying (P<0.001), and had smaller increases in heart rate (P = 0.007) than the neonates in the placebo group. Facial-activity scores were 12 to 49 percent lower during various steps of the procedure in the lidocaine–prilocaine group. As compared with neonates in the placebo group, infants in the lidocaine–prilocaine group cried less than half as much and had heart-rate increases of 10 beats per minute less. Blood methemoglobin concentrations (expressed as a percentage of the hemoglobin concentration) were similar (1.3 percent) in both groups. Lidocaine and prilocaine were detected in plasma in 23 (61 percent) and 21 (55 percent) of the infants treated with lidocaine–prilocaine cream, respectively.

Conclusions Lidocaine–prilocaine cream is efficacious and safe for the prevention of pain from circumcision in neonates.

Source Information

From the Department of Paediatrics, Hospital for Sick Children, Toronto (A.T., B.S., S.B.-D., G.K.); the Faculties of Pharmacy (A.T., G.K.); Nursing (B.S.); and Medicine (G.K.), University of Toronto, Toronto; the Department of Psychology, University of British Columbia, Vancouver (K.C.); and the Department of Newborn and Developmental Paediatrics, Women's College Hospital, Toronto (P.R., A.S., P.M.) — all in Canada.

Address reprint requests to Dr. Koren at the Department of Paediatrics, Hospital for Sick Children, 555 University Ave., Toronto, ON M5G 1X8, Canada.

Full Text of this Article

Related Letters:

Lidocaine–Prilocaine Cream for Pain during Circumcision
Somerville M. A., Alwin D. M., Scherger J. E., Katz M. S., Keleti D., Taddio A., Koren G., Wiswell T. E.
Extract | Full Text  
N Engl J Med 1997; 337:568-570, Aug 21, 1997. Correspondence

This article has been cited by other articles:

• Van Howe, R. S., Svoboda, J. S. (2008). Neonatal pain relief and the helsinki declaration.. J Law Med Ethics 36: 803-823  
• Sharek, P. J., Powers, R., Koehn, A., Anand, K. J.S. (2006). Evaluation and Development of Potentially Better Practices to Improve Pain Management of Neonates. Pediatrics 118: S78-S86 [Abstract] [Full Text]  
• Calhoun, D. A, Murthy, S N., Bryant, B. G, Luedtke, S. A, Bhatt-Mehta, V. (2006). Recent Advances in Neonatal Pharmacotherapy. The Annals of Pharmacotherapy 40: 710-719 [Abstract] [Full Text]  
• Simons, J. M., MacDonald, L. M. (2004). Pain assessment tools: children's nurses' views. J Child Health Care 8: 264-278 [Abstract]  
• Lillieborg, S., Otterbom, I., Ahlen, K., Long, C. (2004). Topical anaesthesia in neonates, infants and children. Br J Anaesth 92: 450-451 [Full Text]  
• Kaur, G., Gupta, P., Kumar, A. (2003). A Randomized Trial of Eutectic Mixture of Local Anesthetics During Lumbar Puncture in Newborns. Arch Pediatr Adolesc Med 157: 1065-1070 [Abstract] [Full Text]  
• Long, C. P., McCafferty, D. F., Sittlington, N. M., Halliday, H. L., Woolfson, A. D., Jones, D. S. (2003). Randomized trial of novel tetracaine patch to provide local anaesthesia in neonates undergoing venepuncture. Br J Anaesth 91: 514-518 [Abstract] [Full Text]  
• Franck, L. S. (2003). Nursing management of children's pain: Current evidence and future directions for research. Journal of Research in Nursing 8: 330-353 [Abstract]  
• Choi, W.Y., Irwin, M.G., Hui, T.W.C., Lim, H.H., Chan, K.L. (2003). EMLA(R) Cream Versus Dorsal Penile Nerve Block for Postcircumcision Analgesia in Children. Anesth. Analg. 96: 396-399 [Abstract] [Full Text]  
• Peters, J. W. B., Koot, H. M., de Boer, J. B., Passchier, J., Bueno-de-Mesquita, J. M., de Jong, F. H., Duivenvoorden, H. J., Tibboel, D. (2003). Major Surgery Within the First 3 Months of Life and Subsequent Biobehavioral Pain Responses to Immunization at Later Age: A Case Comparison Study. Pediatrics 111: 129-135 [Abstract] [Full Text]  
• Committee on Psychosocial Aspects of Child and Fam, , Task Force on Pain in Infants, Children, and Adole, (2001). The Assessment and Management of Acute Pain in Infants, Children, and Adolescents. Pediatrics 108: 793-797 [Abstract] [Full Text]  
• Anand, K. J. S., and the International Evidence-Based Group for Neo, (2001). Consensus Statement for the Prevention and Management of Pain in the Newborn. Arch Pediatr Adolesc Med 155: 173-180 [Abstract] [Full Text]  
• Hill, G., Taddio, A., Koren, G. (2000). Pain Indication in Circumcision. Arch Pediatr Adolesc Med 154: 1275-1275 [Full Text]  
• Larijani, G. E., Cypel, D., Gratz, I., Mroz, L., Mandel, R., Afshar, M., Goldberg, M. E. (2000). The Efficacy and Safety of EMLA(R) Cream for Awake Fiberoptic Endotracheal Intubation. Anesth. Analg. 91: 1024-1026 [Abstract] [Full Text]  
• Taddio, A., Pollock, N., Gilbert-MacLeod, C., Ohlsson, K., Koren, G. (2000). Combined Analgesia and Local Anesthesia to Minimize Pain During Circumcision. Arch Pediatr Adolesc Med 154: 620-623 [Abstract] [Full Text]  
• Rosen, D. A., Morris, J. L., Rosen, K. R., Valenzuela, R. C., Vidulich, M. G., Steelman, R. J., Gustafson, R. A. (2000). Analgesia for Pediatric Thoracostomy Tube Removal. Anesth. Analg. 90: 1025-1028 [Abstract] [Full Text]  
• Committee on Fetus and Newborn, Committee on Drugs, , Canadian Paediatric Society, Fetus and Newborn Com, (2000). Prevention and Management of Pain and Stress in the Neonate. Pediatrics 105: 454-461 [Abstract] [Full Text]  
• Task Force on Circumcision, (1999). Circumcision Policy Statement. Pediatrics 103: 686-693 [Abstract] [Full Text]  
• Kurtis, P. S., DeSilva, H. N., Bernstein, B. A., Malakh, L., Schechter, N. L. (1999). A Comparison of the Mogen and Gomco Clamps in Combination With Dorsal Penile Nerve Block in Minimizing the Pain of Neonatal Circumcision. Pediatrics 103: 23e-23 [Abstract] [Full Text]  
• Van Howe;, R. S., Butler-O'Hara, M., LeMoine, C., Guillet, R. (1999). Pain Relief for Neonatal Circumcision: Serious Design Flaws?. Pediatrics 103: 196-196 [Full Text]  
• Stang, H. J., Snellman, L. W. (1998). Circumcision Practice Patterns in the United States. Pediatrics 101 : e5-e5 [Abstract] [Full Text]  
• Horger III, E. O., Arnett, R. M., Jones, J. S., Andersson, C., Van Howe, R. S., Cold, C. J., Shechet, J., Fried, S. M., Tanenbaum, B., Lander, J., Metcalfe, J. B., Muttitt, S., Brady-Fryer, B. (1998). Local Anesthesia for Infants Undergoing Circumcision. JAMA 279: 1169-1171 [Full Text]  
• Butler-O'Hara, M., LeMoine, C., Guillet, R. (1998). Analgesia for Neonatal Circumcision: A Randomized Controlled Trial of EMLA Cream Versus Dorsal Penile Nerve Block. Pediatrics 101 : e5-e5 [Abstract] [Full Text]  
• Herschel, M., Khoshnood, B., Ellman, C., Maydew, N., Mittendorf, R. (1998). Neonatal Circumcision: Randomized Trial of a Sucrose Pacifier for Pain Control. Arch Pediatr Adolesc Med 152: 279-284 [Abstract] [Full Text]  
• Howard, C. R., Howard, F. M., Garfunkel, L. C., de Blieck, E. A., Weitzman, M. (1998). Neonatal Circumcision and Pain Relief: Current Training Practices. Pediatrics 101: 423-428 [Abstract] [Full Text]  
• Acharya, A B, Bustani, P C, Phillips, J D, Taub, N A, Beattie, R M (1998). Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants. Arch. Dis. Child. Fetal Neonatal Ed. 78: 138F-142 [Abstract] [Full Text]  
• Taddio, A., Ohlsson, A., Einarson, T. R., Stevens, B., Koren, G. (1998). A Systematic Review of Lidocaine-Prilocaine Cream (EMLA) in the Treatment of Acute Pain in Neonates. Pediatrics 101 : e1-e1 [Abstract] [Full Text]  
• Sleep, J. (1998). Lidocaine-prilocaine cream was more effective than placebo for pain during circumcision. Evid. Based Nurs. 1: 9-9 [Full Text]  
• Lander, J., Brady-Fryer, B., Metcalfe, J. B., Nazarali, S., Muttitt, S. (1997). Comparison of Ring Block, Dorsal Penile Nerve Block, and Topical Anesthesia for Neonatal Circumcision: A Randomized Controlled Trial. JAMA 278: 2157-2162 [Abstract]  
• Somerville, M. A., Alwin, D. M., Scherger, J. E., Katz, M. S., Keleti, D., Taddio, A., Koren, G., Wiswell, T. E. (1997). Lidocaine-Prilocaine Cream for Pain during Circumcision. NEJM 337: 568-570 [Full Text]  
• Wiswell, T. E. (1997). Circumcision Circumspection. NEJM 336: 1244-1245 [Full Text]