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Re: Exposure of neonates to unnecessary pain is unethical

Dear Editor

Sahni and colleagues report that 15 neonates were given an unspecified non-invasive analgesic prior to circumcision,[1] which may have been EMLA cream. Test results recorded a significantly elevated heart rate (HR) and reduced oxygen saturation, indicative of pain.[1] The HR remained higher than baseline even after the conclusion of the surgery, suggesting ongoing pain from the tissue damage inflicted. Although the neonates were restrained in a Circumstraint™ device designed to limit motion, "excessive motion" was recorded.[1] This suggests that the neonates may have been severely distressed during the circumcision. Apparently, it was necessary to subject the neonates to the iatrogenic pain of invasive circumcision in order to generate the patient motion that was essential to the success of the study!

EMLA non-invasive topical analgesic ointment may not protect adequately against the intense pain of invasive circumcision because it cannot penetrate deeply enough to be very effective.[2]

In our extensive survey of the clinical literature, my associates and I reported evidence that invasive circumcision pain may be traumatic and that perinatal circumcision-related trauma may be associated with an increased risk of self-destructive behaviour in adult life.[3] Circumcision during infancy or childhood is the recorded stressor in many documented cases of PTSD.[3-5]

In addition, we reported alarming evidence that neonatal pain, stress, and trauma may adversely impact on developing neurological structures.[3] Inadequate pain control in newborns and children is a matter of continuing concern because of reported long-term consequences and behavioural changes.[6,7] Circumcision also removes sexual nerve endings from the penis, which may only adversely affect sexual sensation and response.[3]

This study was approved by an institutional review board (IRB), which apparently turned a "blind eye" to the unethical, unnecessary infliction of pain, trauma, and permanent sexual reduction on unconsenting minors. Painful surgical procedures in children either should be conducted under adequate anaesthesia or such procedures should be avoided altogether.[8] Since currently available methods of pain control for neonatal circumcision do not permit full analgesia,[2] non-therapeutic circumcision, which is not essential for child health, should be avoided. The design and execution of the invasive study by Sahni et al. falls short of best medical practice [9] and fails modern ethical standards[10] because of the deliberate exposure of neonates to unnecessary pain, trauma and subsequent life-long reduced sexual sensation. This IRB has displayed an alarming and distressing lack of vigilance and seems fixated in a pre- human-rights 1940s ethical environment. Evidently, reforms are necessary to implement contemporary medical ethics.

References

(1) Motion resistant pulse oximetry in neonates. Arch Dis Child Fetal Neonatal Ed 2003;88(6):F505. http://adc.bmjjournals.com/cgi/content/full/fetalneonatal%3b88/6/F505

(2) Lander J, Brady-Freyer B, Metcalfe JB, et al. Comparison of ring block, dorsal penile nerve block, and topical anesthesia for neonatal circumcision. JAMA 1997; 278:2158-62. http://jama.ama-assn.org/cgi/content/abstract/278/24/2157

(3) Boyle GJ, Goldman R, Svoboda JS, Fernandez E. Male circumcision: pain, trauma and psychosexual sequelae. Journal of Health Psychology 2002;7(3):329-43. http://www.cirp.org/library/psych/boyle6

(4) Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on pain response during subsequent routine vaccination. The Lancet 1997;349:599-603. http://www.cirp.org/library/pain/taddio2

(5) Ramos S, Boyle GJ. Ritual and medical circumcision among Filipino boys: Evidence of post-traumatic stress disorder. In Denniston GC, Hodges FM, Milos MF., Eds., Understanding circumcision: A multi-disciplinary approach to a multi-dimensional problem. New York: Kluwer/Plenum, 2001.

(6) Sinno SHP, van Dijk M, Anand KS, et al. Do We Still Hurt Newborn Babies? A Prospective Study of Procedural Pain and Analgesia in Neonates. Arch Pediatr Adolesc Med 2003;157(11):1058-64. http://archpedi.ama-assn.org/cgi/content/abstract/157/11/1058

(7) Howard RF. Current Status of Pain Management in Children. JAMA 2003;290(18):2464-9. http://jama.ama-assn.org/cgi/content/abstract/290/18/2464

(8) Canadian Paediatic Society Fetus and Newborn Committee, American Academy of Pediatrics Committee on Fetus and Newborn. Prevention and management of pain and stress in the neonate. Pediatrics 2000;105(2):454- 461. http://aappolicy.aappublications.org/cgi/content/full/pediatrics;105/2/454

(9) Fletcher AB. Pain in the Neonate (Editorial). N Engl J Med 1987;317(21):1347-48. http://www.cirp.org/library/pain/fletcher