Letter Responses to Taddio et al.

Neonatal circumcision

Sir

Taddio and colleagues (March 1, p 599)¹ clearly demonstrate that neonatal circumcision has a long-term psychological impact on the developing neonate, leaving circumcised boys with symptoms similar to post-traumatic stress disorder.² The results of their preliminary study³ prompted several international organisations, such as the Australian Association of Paediatric Surgeons, to condemn neonatal circumcision, and their new study validates this condemnation. On the basis of their preliminary findings, Taddio et al recommended anaesthetic for neonatal circumcision; however, their latest study has failed to support their hypothesis that topical anaesthetic would protect boys from the effect of circumcision on later response to painful situations, which is not surprising.

In their recent review of published work, Puthoff and colleagues⁴ concluded that lidocaine-prilocaine cream (EMLA) has been shown to be neither a safe nor an effective anaesthetic for neonatal circumcision. On the basis of present information EMLA cannot be recommended for this procedure. When Taddio and colleagues recommended the use of local anaesthetic in their preliminary study, several workers responded to the editor that a recommendation against neonatal circumcision would have been more appropriate.⁵ After this recent study, Taddio et al recommend pretreatment and postoperative management of neonatal circumcision pain¹ which is laudable. However, now that other confounding factors have been controlled for and it is clear that neonatal circumcision either with or without anaesthetic may induce long-lasting changes in infant pain behaviour because of alterations in the infant's central neural processing of painful stimuli, what prevents them from denouncing a procedure with no clearly proven medical benefit?

Sir

Taddio and colleagues¹ recommend pretreatment with EMLA in circumcision. All newborn babies encounter painful experiences before birth, during delivery, and during the first week of life.² Painful events such as intramuscular vitamin K administration and the Guthrie test are routinely done without analgesia during the first week of life. Furthermore, infants requiring intensive care may receive a multitude of small yet painful stimuli. We investigated the pain response to antecubital venepuncture in 25 sedated newborn infants to evaluate whether pretreatment with lidocaine/prilocaine 5% cream (EMLA, Astra) alters the pain response.

All 25 babies were in our intensive care unit and were mechanically ventilated with a Siemens 300 ventilator in pressure-regulated volume control mode. None of the 25 infants had evidence of brain damage. Stable haemodynamic and ventilatory conditions together with the absence of recent (<12 h) painful procedure was a prerequisite for inclusion in the study. Sedation was achieved by continous administration of midazolam (006 mg kg1 h1; Roche). The strength of the pain response to the venepuncture was measured with the Comfort score,³ which can be used to assess distress during painful or distressing procedures in ventilated patients.

12 babies (32 [SD 11] weeks) were pretreated with EMLA and 13 (30 [13]) with placebo cream. The cream was applied 90 minutes before venepuncture. In infants pretreated with EMLA Comfort score evaluation before and after venepuncture did not differ. In the placebo-group, however, a significant increase in Comfort score (256 [72] vs 327 [22], p<005 unpaired t-test) after venepuncture was seen. Moreover, Comfort score values required several hours (42 [31] h) to return to baseline values. The protective effect of EMLA cream on painful cutaneous procedures in newborn babies is supported by our data, despite the concomitant use of sedative drugs.

Sir

We commend Taddio and colleagues¹ on the intention of their study. As primary care physicians we should be ever vigilant for the comfort of our patients, and any effort we can make to identify and alleviate suffering will always be of benefit. However, when such a study is undertaken it is imperative that the conclusions be generalisable to most populations. In our particular hospital we do about 500 neonatal circumcisions per year. Dorsal penile nerve blockade with 1% lidocaine without epinephrine is the exclusive method, and anaesthetic agent is used in most of these patients. EMLA is occasionally used on our paediatric ward for phlebotomy and insertion of intravenous lines with only fair success.

Taddio and co-workers chose to use EMLA for anaesthesia, rather than the more effective dorsal penile nerve block, but note in their discussion: study of the vaccination pain response of infants who had received more effective circumcision pain management (ie, dorsal penile nerve block and adequate postoperative pain management) would be interesting.¹ Use of a gold standard for anaesthesia in this setting would have made their conclusions more convincing. The intention of this study was noble and will certainly help primary care physicians understand and better treat pain in all our patients. However, until proper study of dorsal penile nerve block is undertaken, evaluation of subsequent pain response cannot be adequately examined.

Sir

After reading Taddio and colleagues' report¹ two issues remain unresolved. First, why did the research ethics board of the Hospital for Sick Children and Women's College Hospital approve painful, elective surgery on infants without anaesthesia? If this experimental protocol had been proposed in research animals, the arm of the study without anaesthesia would have been disallowed. When parents and patients discover that your institution is undertaking painful experiments on infants without anaesthesia that would not be allowed in animal research, would they come to distrust your institution in the manner that many African-American males distrust research protocols since the Tuskeegee Syphilis Study was published?² As physicians, we should first do no harm. If we agree that useless pain may have long-term negative effects, then painful, elective surgery should not be allowed without adequate anaesthesia.

Second, since parental consent may not be adequate for painful, unanaesthetised, cosmetic surgery on infants,^3-5 I suggest that circumcisions be done on consenting adults. Adults could describe the pain associated with unanaesthetised circumcision and, therefore, the pain assessment would be less inferential. Although the pain assessment in an adult study would be less abstract, I fear volunteers would be hard to find.

(Return to Taddio article)

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