Correspondence
Lidocaine–Prilocaine Cream for Pain during Circumcision
N Engl J Med 1997; 337:568-570August 21, 1997
- Article
To the Editor:
The study by Taddio et al. (April 24 issue)1 raises several troubling questions. First, if neonatal circumcision is not undertaken for medical reasons, is it ethical to conduct medical research on it? In the vast majority of cases, circumcision is done for religious or cultural reasons. The Canadian Paediatric Society reviewed the literature extensively and concluded that any small medical benefits do not outweigh the risks and that neonatal circumcision should not be routinely performed.2 Moreover, neonatal circumcision is done without the consent of the subject, removes healthy tissue with a unique anatomical structure and function, and leads to differences in adult sexual behavior.3
Circumcision can be deeply connected with religious belief, and any interference with this requires profound consideration and justification. We need, therefore, to address the issue directly and end the persistent efforts to find a medical rationale for circumcision by removing the cloak of medicine from this procedure. Should nonmedical infant circumcision or research involving it be carried out, and if so, should it be conducted by physicians, and under what conditions?
Second, assuming that it was ethically acceptable for Taddio et al. to undertake this study, was it ethical for them to include in it a group of infants circumcised without anesthesia? Generally accepted principles governing the ethics of research require clinical equipoise 4 — that is, before a randomized trial can be undertaken, the generally accepted medical opinion must be that no one treatment is superior to another, and the researchers must share this opinion. In this case, was there clinical equipoise at the outset of the study?
4 ReferencesMargaret A. Somerville, F.R.S.C., LL.D.
McGill Centre for Medicine, Ethics, and Law, Montreal, QC H3A 1W9, CanadaDavid M. Alwin, M.D.
St. Mary's Hospital, Montreal, QC H3T 1M5, Canada1
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
Full Text | Web of Science | Medline2
Fetus and Newborn Committee, Canadian Paediatric Society
Web of Science3
Laumann EO ,Masi CM ,Zuckerman EW . Circumcision in the United States: prevalence, prophylactic effects, and sexual practice. JAMA 1997;277:1052-1057
CrossRef | Web of Science | Medline4
Freedman B . Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-145
Full Text | Web of Science | Medline
To the Editor:
With safe, effective, and easy-to-administer techniques available, it is inexcusable to perform circumcision without anesthesia. Newborns cannot talk, but their cries attest to their discomfort. Unfortunately, the excellent study by Taddio et al. describes only a partially effective and slow technique and misrepresents a better one.
The authors state that dorsal penile nerve block and subcutaneous infiltration of lidocaine in the foreskin are “rarely used because they require skills that most physicians have not acquired.”1 Since the articles describing the injection techniques first appeared,2-4 I have worked in hospitals in three different regions and have seen the use of the techniques become widespread. Nurses and physicians in newborn nurseries have been teaching them on the spot. The maxim “See one, do one, teach one” clearly applies in the case of simple local anesthesia. After the injection, the babies are calm while the circumcision is performed.
At national meetings I have informally surveyed family physicians working in obstetrics and newborn care, and I find that these methods are widely used. The results of a randomized, controlled trial of methods of injection favored dorsal penile nerve block.5 It is simple, safe, and more effective than topical cream.
5 ReferencesJoseph E. Scherger, M.D., M.P.H.
University of California, Irvine, Irvine, CA 926971
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
Full Text | Web of Science | Medline2
Stang HJ ,Gunnar MR ,Snellman L ,Condon LM ,Kestenbaum R . Local anesthesia for neonatal circumcision: effects on distress and cortical response. JAMA 1988;259:1507-1511
CrossRef | Web of Science | Medline3
Toffler WL ,Sinclair AE ,White KA . Dorsal penile nerve block during newborn circumcision: underutilization of a proven technique? J Am Board Fam Pract 1990;3:171-174
Medline4
Fontaine P ,Toffler WL . Dorsal penile nerve block for newborn circumcision. Am Fam Physician 1991;43:1327-1333
Web of Science | Medline5
Lenhart JG ,Lenhart NM ,Reid A ,Chong BK . Local anesthesia for circumcision: which technique is most effective? J Am Board Fam Pract 1997;10:13-19
Medline
To the Editor:
At our center we circumcise babies up to 18 months of age, using lidocaine–prilocaine cream for analgesia, the Mogen circumcision instrument for the procedure, and styptic powder, when necessary, for hemostasis.
After many years with the Gomco instrument, we changed to the Mogen circumcision instrument. The number of times the prepuce is pinched, pulled, clamped, or cut can be reduced from about 15 with the former to 5 with the latter, and the length of time required with the Gomco instrument to remove the prepuce (9 minutes) and complete the entire procedure (13 to 16 minutes) can be reduced to 45 seconds and 3 minutes, respectively.
We do not recommend dorsal penile nerve block. It is very likely that the pain of the block alone exceeds that of the entire circumcision done with lidocaine–prilocaine cream and the Mogen instrument. Using this instrument allows both time and tissue handling to be greatly reduced.
Murray S. Katz, M.D.C.M.
Tiny Tots Medical Centre, Dollard-des-Ormeaux, QC H9B 2Y1, CanadaTo the Editor:
After providing evidence that newborn boys undergoing circumcision feel pain, Dr. Wiswell (April 24 issue)1 recommends the use of analgesia during the procedure. He portrays circumcision as a standard medical practice that conveys certain health benefits and that can be done less painfully with analgesia. Yet this procedure is not as prevalent in many other countries as in the United States, and its health benefits are minimal and possibly nonexistent when good personal hygiene is practiced. Among the industrialized countries, the United States has one of the highest circumcision rates. According to government data, 63 percent of boys born in 1993 in the United States were circumcised, as compared with 11 percent of those born in Australia and even smaller proportions in Germany and Japan. It appears that the health professionals in those countries think it unnecessary to circumcise 500 to 100,000 newborns — depending on whose data one believes — to prevent 1 case of penile cancer in an older man with poor hygiene. The health benefits with regard to the reduced frequency of sexually transmitted disease are even more questionable.
I understand that there are cultural and religious reasons for which parents choose to have their newborn boys circumcised. But when circumcision is done for nonreligious reasons and for no clear health benefit, is it appropriate to perform an elective operation that permanently alters the anatomy of a male newborn when he is not of an age to give informed consent? Why not wait until the child is old enough to make his own decision based on health or other personal reasons? If that happened, I am sure that circumcision rates in the United States would quickly fall to the level of those in other industrialized countries, such as Australia and Japan.
1 ReferencesDaniel Keleti, M.D.
David Grant Medical Center, Travis AFB, CA 945351
Wiswell TE . Circumcision circumspection. N Engl J Med 1997;336:1294-1295
Full Text | Web of Science
Author/Editor Response
The authors reply:
To the Editor: Drs. Somerville and Alwin question the ethics of circumcision for nonmedical reasons. Although opinions about this practice differ, approximately 40 percent of male infants in North America are currently circumcised. In our study, all the circumcisions were performed in medical settings, not as part of a religious ceremony. Since the standard practice was not to provide analgesia, we considered it ethical to include a placebo group. Studies of the relief of pain during circumcision are approved by ethics boards all over the world. Our data should neither be interpreted as justifying circumcision nor be used to promote it.
We agree with Dr. Scherger that regional nerve blocks (such as dorsal penile nerve blocks) may be more effective than topical analgesia and that they are used more when physicians are taught the injection technique. Unfortunately, recent surveys of analgesic practices during circumcision have shown that nerve blocks (and other such methods) are rarely used.1,2 We believe that practice guidelines that impose a minimal standard for the management of pain during circumcision will also increase the use of nerve blocks and other analgesic techniques.
Dr. Katz states that the pain of the block probably exceeds that of the circumcision. This opinion is not only unsubstantiated by medical research but inconsistent with the amount of tissue damage caused by needle pricks as compared with circumcision. It also ignores the postoperative pain caused by continued afferent neural stimulation arising from the surgical site. A trial evaluating the pain associated with injections preceded by the application of lidocaine–prilocaine cream to the injection site may show that the pain is decreased.
Overall, it is encouraging to see that physicians are more concerned than in the past about ensuring effective analgesia during neonatal circumcision. This concern is the driving force behind the effort to adopt effective and safe methods.
2 ReferencesAnna Taddio, Ph.D.
Gideon Koren, M.D.
Hospital for Sick Children, Toronto, ON M5G 1X8, Canada1
Howard CR ,Howard FM ,Garfunkel L ,deBlieck EA ,Weitzman M . Neonatal circumcision and pain relief: current training practices. Arch Pediatr Adolesc Med 1996;150:Suppl:P42-P42 abstract.2
Wellington N ,Rieder MJ . Attitudes and practices regarding analgesia for newborn circumcision. Pediatrics 1993;92:541-543
Web of Science | Medline
Author/Editor Response
Dr. Keleti incorrectly states that the health benefits of neonatal circumcision are minimal. That there are multiple benefits was recognized in 1989 by the Task Force on Circumcision of the American Academy of Pediatrics.1 Good personal hygiene may prevent the disorders associated with the uncircumcised state, but there are no scientific data to support this speculation. Keleti misinterprets the data on the incidence of penile cancer. In the United States, the overall incidence of this cancer is 1 per 100,000 per year of life, or approximately 75 per 100,000 during each man's lifetime. Because nearly all cases of penile cancer occur in the 30 percent of American men who are uncircumcised, the incidence of the cancer in that group would be 250 per 100,000.
Dr. Keleti is also incorrect about the reduced frequency of sexually transmitted diseases. In the more than 100 publications to address the issue, virtually every sexually transmitted disease has been found to be more common among uncircumcised men. Moreover, among 33 cross-sectional epidemiologic studies that have assessed the relation between an intact prepuce and an increased risk of human immunodeficiency virus infection, 27 substantiated this relation.
Parents are the logical surrogates to give consent on behalf of their children. They have the legal right to authorize medical care and treatment for their progeny.2 The overriding principle is to act in the child's best interest. Since the potential medical benefits start immediately after the procedure, parents may choose to give proxy consent during the neonatal period. The Committee on Bioethics of the American Academy of Pediatrics endorses decision making by the parents commensurate with the development of their children.3
3 ReferencesThomas E. Wiswell, M.D.
Thomas Jefferson University, Philadelphia, PA 191071
Report of the Task Force on Circumcision
Web of Science | Medline2
Wiswell TE . Neonatal circumcision: a current appraisal. Focus Opin Pediatr 1995;1:93-993
American Academy of Pediatrics Committee on Bioethics
Web of Science | Medline
- Citing Articles (1)
Citing Articles
1
Robert S. Van Howe, J. Steven Svoboda. (2008) Neonatal Pain Relief and the Helsinki Declaration. The Journal of Law, Medicine & Ethics 36:4, 803-823
CrossRef
