Lidocaine 4% Cream Compared with Lidocaine 2.5% and Prilocaine 2.5% or Dorsal Penile Block for Circumcision

Victoria Tutag Lehr; Eugene Cepeda; Daniel A. C. Frattarelli; Ron Thomas; Jennifer LaMothe; J. V. Aranda

doi:10.1055/s-2005-871655

American Journal of Perinatology, Table of Contents

Am J Perinatol 2005; 22(5): 231-237
DOI: 10.1055/s-2005-871655

Lidocaine 4% Cream Compared with Lidocaine 2.5% and Prilocaine 2.5% or Dorsal Penile Block for Circumcision

Victoria Tutag Lehr¹ ^, ² , Eugene Cepeda² , Daniel A. C. Frattarelli² , Ron Thomas² , Jennifer LaMothe² , J. V. Aranda²

¹Department of Pharmacy Practice, The Eugene Applebaum College of Pharmacy & Health Sciences, Pediatric Pharmacology Research Unit, Children's Hospital of Michigan, Detroit, Michigan
²Department of Pediatrics, Wayne State University School of Medicine, Division of Clinical Pharmacology & Toxicology, Pediatric Pharmacology Research Unit, Children's Hospital of Michigan, Detroit, Michigan

Abstract

ABSTRACT

This study evaluated the efficacy and safety of lidocaine 4% cream (LMX4), compared with lidocaine 2.5% and prilocaine 2.5% (EMLA) or dorsal penile block (DPNB) for analgesia during circumcision. Healthy, term males (n = 54), younger than 1 week old undergoing circumcision were randomly assigned to open-label pretreatment with LMX4, EMLA, or DPNB. Heart rate (HR; beats per minute [bpm]), respiratory rate (RR; breaths/minute), and arterial oxygen saturation as measured by pulse oximetry (Spo ₂; %) were monitored at baseline, and during drug application, circumcision, and recovery. Mean differences were compared using the general linear model. At the end of drug application, mean HR for infants receiving LMX4 (146 bpm; standard error of mean [SEM], 8.0 bpm) was lower than that for DPNB (176 bpm; SEM, 8.3 bpm; p < 0.05). No significant difference in mean HR was observed between treatments during circumcision. Mean RR was higher during circumcision for EMLA compared with LMX4 (p < 0.05) and DPNB (p < 0.05). At lysis, mean RR was significantly lower in DPNB than LMX4 and EMLA. The number of Spo ₂ samples was too small for comparison. Three infants (one receiving LMX4 and two receiving EMLA) experienced local reactions (p = 0.54). No adverse effects were observed with DPNB. No difference in analgesic efficacy was observed between treatments according to HR. Differences in RR may reflect a varying level of analgesia. The safety profile was similar for all treatments. LMX4 is an effective analgesic for newborn circumcision.

KEYWORDS

Analgesia - lidocaine 4% cream - newborn circumcision

Full Text

References

REFERENCES

1 Lander J, Brady-Freyer B, Metcalfe J B, Nazarali S, Muttitt S. Comparison of ring block, dorsal penile nerve block, and topical anesthesia for neonatal circumcision. JAMA. 1997; 278 2157-2162
2 Arnett R M, Jones J S, Horger III E O. Effectiveness of 1% lidocaine dorsal penile nerve block in infant circumcision. Am J Obstet Gynecol. 1990; 163 1074-1078
3 Holliday M A, Pinckert T L, Keirnan S C, Kunos I, Angelus P, Keszler M. Dorsal penile nerve block vs topical placebo for circumcision in low-birth-weight neonates. Arch Pediatr Adolesc Med. 1999; 153 476-480
4 Taddio A, Stevens B, Craig K et al.. Efficacy and safety of lidocaine-prilocaine cream for pain during circumcision. N Engl J Med. 1997; 336 1197-1201
5 Howard C R, Howard F M, Fortune K et al.. A randomized, controlled trial of an eutectic mixture of local anesthetic cream (lidocaine and prilocaine) versus penile nerve block for pain relief during circumcision. Am J Obstet Gynecol. 1999; 181 1506-1511
6 Benini F, Johnston C, Faucher D, Aranda J V. Topical anesthesia during circumcision in newborn infants. JAMA. 1993; 270 850-853
7 Kirya C, Werthmann M W. Neonatal circumcision and penile dorsal nerve block: a painless procedure. J Pediatr. 1978; 92 998-1000
8 Stang H J, Gunnar M R, Snellman L W, Condon L M, Kestenbaum R. Local anesthesia for neonatal circumcision: effects on distress and cortisol response. JAMA. 1988; 259 1507-1511
9 Masciello A L. Anesthesia for neonatal circumcision: local anesthesia is better that dorsal penile nerve block. Obstet Gynecol. 1990; 75 834-838
10 Butler-O'Hara M, LeMoine C, Guillet R. Analgesia for neonatal circumcision: a randomized controlled trial of EMLA cream versus dorsal penile nerve block. Pediatrics. 1998; 101 1-5
11 Jakobson B, Nilsson A. Methemoglobinemia associated with prilocaine-lidocaine cream and trimethoprim-sulfamethoxazole: a case report. Acta Anaesthesiol Scand. 1985; 29 453-455
12 Kumar A R, Dunn N, Naqvi M. Methemoglobinemia associated with prilocaine-lidocaine cream. Clin Pediatr (Phila). 1997; 36 239-240
13 L.M.X.4 (lidocaine 4%) Topical Anesthetic Cream [package insert]. Ferndale, MI; Ferndale Laboratories, Inc September 2003
22 Essink-Tjebbes C M, Hekster Y A, Liem K D, van Dongen R T. Topical use of local anesthetics in neonates. Pharm World Sci. 1999; 21 173-176
14 Anand K. The biology of pain perception in newborn infants. Adv Pain Res Ther. 1990; 15 113-122
15 Goldman R D, Koren G. Biologic markers of pain in the valnerable infant. Clin Perinatol. 2002; 29 415-425
16 Marchette L, Main R, Redick E. Pain reduction during neonatal circumcision. Pediatr Nurs. 1989; 15 207-210
17 Oberlander T, Saul J P. Methodological considerations for the use of heart rate variability as a measure of pain reactivity in vulnerable infants. Clin Perinatol. 2002; 29 427-443
18 Taddio A, Nulman I, Goldbach M. Use of lidocaine-prilocaine cream for vaccination pain in infants. J Pediatr. 1994; 124 643-648
19 Eichenfield L F, Funck A, Fallon-Friedlander S, Cunningham B B. 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. Pediatrics. 2002; 109 1093-1099
20 Taddio A, Ohlsson K, Ohlsson A. Lidocaine-prilocaine cream for analgesia during circumcision of newborn boys (Cochrane Review) In: The Cochrane Library, Issue 4. Oxford; Update Software 2000
21 Evans N J, Rutter N. Development of the epidermis in the newborn. Biol Neonate. 1986; 49 74-80
23 Essink-Tebbes C M, Wuis E W, Liem K D, van Dongen R TM, Heskter Y S. Safety of lidocaine-prilocaine cream application four times a day in premature neonates: a pilot study. Eur J Pediatr. 1999; 158 421-423
24 Berardesca E, Maibach H. Racial differences in skin pathophysiology. J Am Acad Dermatol. 1996; 34 667-672
25 Riendeau L A, Bennett D, Black-Noller G, Fan L, Scavone J M. Evaluation of the analgesic efficacy of EMLA cream in volunteers with differing skin pigmentation undergoing venipuncture. Reg Anesth Pain Med. 1999; 24 165-169
26 Porter F L, Grunau R VE, Anand K JS. Long-term effects of neonatal pain. J Dev Behav Pediatr. 1999; 20 253-261
27 Simons S HP, van Dijk M, Anand K JS, Roofhooft D, van Lingen R A, Tibboel D. Do we still hurt newborn babies? A prospective study of procedural pain and analgesia in neonates. Arch Pediatr Adolesc Med. 2003; 157 1058-1064
28 Anand K JS. Consensus statement for the prevention and management of pain in the newborn. International Evidence-Based Group for Neonatal Pain. Arch Pediatr Adolesc Med. 2001; 155 173-180

Victoria Tutag LehrPharm.D.

Division of Clinical Pharmacology & Toxicology, 3N47

Children's Hospital of Michigan

3901 Beaubien, Detroit, MI 48201