Neonatal Pain Relief and the Helsinki Declaration

World Medical Association Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects,” available at <http://www.wma.net/e/policy/b3.htm> (last visited September 22, 2008).

Department of Health and Human Services, Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, Part 46 Protection of Human Subjects, 45 C.F.R. §46.

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See Masciello , supra note 11.

American Academy of Pediatrics, “Report of the Task Force on Circumcision,” Pediatrics 84, no. 2 (1989): 388–391.

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Jecker N. S. , “Exploiting Subjects in Placebo-controlled Trials,” American Journal of Bioethics 2, no. 2 (2002): 19–20.

Taddio A. Stevens B. Craig K. , “Efficacy and Safety of Lidocaine-Prilocaine Cream for Pain during Circumcision,” New England Journal of Medicine 336, no. 17 (1997): 1197–1201.

Butler-O'Hara M. LeMoineand C. Guillet R. , “Analgesia for Neonatal Circumcision: A Randomized Controlled Trial of EMLA Cream Versus Dorsal Penile Nerve Block,” Pediatrics 101, no. 4 (1998): E5; Herschel M. Khoshnood B. Ellman C. , “Neonatal Circumcision: Randomized Trial of a Sucrose Pacifier for Pain Control,” Archives of Pediatrics & Adolescent Medicine 152, no. 3 (1998): 279–284; Howard C. R. Howard F. M. Fortune K. , “A Randomized, Controlled Trial of a Eutectic Mixture of Local Anesthetic Cream (lidocaine and Prilocaine) Versus Penile Nerve Block for Pain Relief during Circumcision,” American Journal of Obstetrics and Gynecology 181, no. 6 (1999): 1506–1511; Lander J. Brady-Fryer B. Metcalfe J. B. , “Comparison of Ring Block, Dorsal Penile Nerve Block, and Topical Anesthesia for Neonatal Circumcision: A Randomized Controlled Trial,” Journal of the American Medical Association 278, no. 24 (1997): 2157–2162.

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Committee on Bioethics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 95, no. 2 (1995): 314–317.

Dwyer J. G. , “Parents' Religion and Children's Welfare: Debunking the Doctrine of Parents' Rights,” California Law Review 82, no. 6 (1994): 1371–1447; Dwyer J. G. , “The Children We Abandon: Religious Exemptions to Child Welfare and Education Laws as Denials of Equal Protection to Children of Religious Objectors,” North Carolina Law Review 74 (1996): 1321–1478.

Mason S. , “Obtaining Informed Consent for Neonatal Randomised Controlled Trials — An ‘Elaborate Ritual’?” Archives of Disease in Childhood 76, no. 3 (1997): F143–F145.

See Butler-O'Hara , supra note 23.

Id.; Mohan C. G. Risucci D. A. Casimir M. , “Comparison of Analgesics in Ameliorating the Pain of Circumcision,” Journal of Perinatology 18, no. 1 (1998): 13–19.

Svoboda J. S. Van Howe R. S. Dwyer J. G. , “Informed Consent for Neonatal Circumcision: An Ethical and Legal Conundrum,” Journal of Contemporary Health Law and Policy 17, no. 1 (2000): 61–133.

See Svoboda , supra note 30.

Cold C. J. , “Neonatal Circumcision,” The Lancet 349, no. 9060 (1997): 1257–1258.

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See Taddio , supra note 22.

Poland R. L. Roberts R. J. Guitierrez-Mazorra J. F. , Committee on Fetus and Newborn, Committee on Drugs, Section on Anesthesiology, Section on Surgery, “Neonatal Anesthesia,” Pediatrics 80, no. 3 (1987): 446.

Ferguson K. J. Caplan R. M. Williamson P. S. , “Factors Associated with Behavior Change in Family Physicians after CME Presentation,” Journal of Medical Education 59, no. 8 (1984): 662–666; Stang H. J. Snellman L. W. , “Circumcision Practice Patterns in the United States,” Pediatrics 101, no. 6 (1998): E5; Toffler W. L. Sinclair A. E. White K. A. , “Dorsal Penile Nerve Block during Newborn Circumcision: Underutilization of a Proven Technique?” Journal of the American Board of Family Practice 3, no. 3 (1990): 171–174; Wellington N. Rieder M. J. , “Attitudes and Practices Regarding Analgesia for Newborn Circumcision,” Pediatrics 92, no. 4 (1993): 541–543.

See Poland , supra note 36.

Carlsson P. Svensson J. , “The Duration of Pain Relief after Penile Block to Boys Undergoing Circumcision,” Acta Anaesthesioliologica Scandinavica 28 (1984): 432–434; Franci Ventosa S. Espinosa Soldevila W. , “Utilidad del Bloqueo Peneano en la Analgesia Postoperatoria de Intervenciones de Circuncision,” [Usefulness of penile blockade in postoperative analgesia of circumcision procedures] Revista Española de Anestesiollogía y Reanimación 37, no. 4 (1990): 238–240; McGowan P. R. May H. Molnar Z. Cunliffe M. , “A Comparison of Three Methods of Analgesia in Children Having Day Case Circumcision,” Paediatric Anaesthesia 8, no. 5 (1998): 403–407; Martinez Telleria A. Cano Serrano M. E. Martinez Telleria M. J. , “Analisis de la Eficacia Analgesica de la Anestesia Locorregional en Cirugia Infantil,” [Analysis of regional anesthetic efficacy on pediatric postoperative pain] Cirugía Pediátrica 10, no. 1 (1997): 18–20; Murphy D. F. Gallagher E. M. , “Dorsal Nerve Blockade for Pain Relief after Circumcision,” Irish Journal of Medical Science 153, no. 8 (1984): 282–283, Nielsen P. A. Jorgensen L. Fonsmark L. , “Penisblok til Phimosisoperation. Peroperativt Anlagt Som Postoperativ Analgesi Hos Born,” [Penile block in circumcision. Peroperative use as postoperative analgesia in children] Ugeskrift for Laeger 150, no. 22 (1988): 1348–1350; Ramboatiana R. Gassner C. Schoch J. P. , “Analgesie Post-operatoire pour la Circoncision Chez L'enfant,” [Postoperative analgesia for circumcision in children] Agressologie 31, no. 1 (1990): 39–42; Rodrigo M. R. Ong L. L. Waheed A. A. , “Dorsal Nerve Block of Penis in Chinese Children,” British Journal of Anaesthesia 56, no. 8 (1984): 934–935; Van Zundert A. , “Penile Dorsal Nerve Block for Penile Surgery,” Acta Anaesthesiology Belgium 36, no. 1 (1985): 41–46; Wong K. M. , “[Penile Block for Postoperative Pain Relief in Children]” Ma Tsui Hsueh Tsa Chi 24, no. 3 (1986): 193–195.

See Anand Hickey , supra note 6.

See Leditschke , supra note 24.

See Miller Brody , supra note 20.

See Cold , supra note 32

Hardwick-Smith S. Mastrobattista J. M. Wallace P. A. , “Ring Block for Neonatal Circumcision,” Obstetrics and Gynecology 91, no. 6 (1998): 930–934.

See Mohan , supra note 29.

Kurtis P. S. DeSilva H. N. Bernstein B. A. , “A Comparison of the Mogen and Gomco Clamps in Combination with Dorsal Penile Nerve Block in Minimizing the Pain of Neonatal Circumcision,” Pediatrics 103, no. 2 (1999): E23.

Kass F. C. Holman J. R. , “Oral Glucose Solution for Analgesia in Infant Circumcision,” Journal of Family Practice 50, no. 9 (2001): 785–788.

See Herschel , supra note 23; Herschel M. , Letter to the Editor, “Circumcision — the Debates Goes On,” Pediatrics 105, no. 3, Part 1 (2000): 681.

See Lander , supra note 23.

Freedman B. , “Equipoise and the Ethics of Clinical Research,” New England Journal of Medicine 317, no. 3 (1987): 141–145.

See Benini , supra note 17.

See Taddio , supra note 22.

See Butler-O'Hara , supra note 23.

Hill G. , Letter to the Editor, “Pain Indication in Circumcision,” Archives of Pediatrics & Adolescent Medicine 154, no. 12 (2000): 1275.

Taddio A. Koren G. , Response to Letter to the Editor, “Pain Indication in Circumcision,” Archives of Pediatrics & Adolescent Medicine 154, no. 12 (2000): 1275.

See Taddio , supra note 22; Taddio A. Katz J. Ilersich A. L. Koren G. , “Effect of Neonatal Circumcision on Pain Response during Subsequent Routine Vaccination,” The Lancet 349, no. 9052 (1997): 599–603.

See Miller , supra note 20.

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendations, DHEW Publication No. (OS) 77–0004, Washington, D.C., at Appendix; DHEW Publication No. (OS) 77–0005, 1977, both cited in Levine R. J. , Ethics and Regulation of Clinical Research, 2nd ed. (New Haven: Yale University Press, 1986).

Ganiats T. G. Humphrey J. B. Taras H. L. , “Routine Neonatal Circumcision: A Cost-Utility Analysis,” Medical Decision Making 11, no. 4 (1991): 282–293; Van Howe R. S. , “A Cost-Utility Analysis of Neonatal Circumcision,” Medical Decision Making 24, no. 6 (2004): 584–601.

Taddio A. Goldbach M. Ipp M. , “Effect of Neonatal Circumcision on Pain Responses during Vaccination in Boys,” The Lancet 345, no. 8945 (1995): 291–292; see Taddio , supra note 56.

See Taddio , supra note 22.

Kowalski C. J. , “Placebo Controls: Scientific and Ethical Issues,” American Journal of Bioethics 2, no. 2 (2002): 33–34.

Porter F. L. Porges S. W. Marshall R. E. , “Newborn Pain Cries and Vagal Tone: Parallel Changes in Response to Circumcision,” Child Development 59, no. 2 (1988): 495–505.

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Gunnar M. R. Fisch R. O. Korsvik S. , “The Effects of Circumcision on Serum Cortisol and Behavior,” Psychoneuroendocrinology 6, no. 3 (1981): 269–275; Gunnar M. R. Fisch R. O. Malone S. , “The Effects of a Pacifying Stimulus on Behavioral and Adrenocortical Responses to Circumcision in the Newborn,” Journal of the American Academy of Child Psychiatry 23, no. 1 (1984): 34–38; Gunnar M. R. Malone S. Vance G. , “Coping with Aversive Stimulation in the Neonatal Period: Quiet Sleep and Plasma Cortisol Levels during Recovery from Circumcision,” Child Development 56, no. 4 (1985): 824–834; Gunnar M. R. Connors J. Isensee J. , 'Adrenocortical Activity and Behavioral Distress in Human Newborns,” Developmental Psychobiology 21, no. 4 (1988): 297–310; Talbert L. M. Kraybill E. N. Potter H. D. , “Adrenal Cortical Response to Circumcision in the Neonate,” Obstetrics and Gynecology 48, no. 2 (1976): 208–210.

See Lander , supra note 23; see Mohan , supra note 29.

See Gunnar (1995), supra note 65.

Holton M. E. , “Comparison of Newborn Circumcision Pain to Calcaneal Heel Puncture Pain: Is Newborn Circumcision Pain Control Clinically Warranted?” Journal of the American Osteopathic Association 96 (1996): 31–33.

Williamson M. L. , “Circumcision Anesthesia: A Study of Nursing Implications for Dorsal Penile Nerve Block,” Pediatric Nursing 23, no. 1 (1997): 59–63.

See Butler-O'Hara , supra note 23.

See Mohan , supra note 29.

See Taddio , supra note 22.

Brady-Fryer B. , “A Dilemma in Infant Research: Can It Be Ethical to Have a Treatment Group in Which Pain Is Not Treated?” Bioethics Bulletin 7, no. 1 (1995).

See Butler-O'Hara , supra note 23.

Citation in Angell , supra note 33; Angell M. , “Ethical Imperialism? Ethics in International Collaborative Clinical Research,” New England Journal of Medicine 319, no. 16 (1988): 1081–1083.

See Angell , supra note 33.

Wiswell T. E. , “Circumcision Circumspection,” New England Journal of Medicine 336, no. 17 (1997): 1244–1245.

Castellsagué X. Bosch F. X. Muñoz N. , “Male Circumcision, Penile Human Papillomavirus Infection, and Cervical Cancer in Female Partners,” New England Journal of Medicine 346, no. 15 (2002): 1105–1112.

Maxwell L. G. Yaster M. , “Analgesia for Neonatal Circumcision: No More Studies, Just Do It,” Archives of Pediatrics & Adolescent Medicine 153, no. 5 (1999): 444–445.

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Veatch R. M. , “Subject Indifference and the Justification of Placebo-Controlled Trials,” American Journal of Bioethics 2, no. 2 (2002): 12–13.

See Committee on Bioethics, supra note 25.

See Lander , supra note 23.

See Brady-Fryer , supra note 75.

Mastrobattista J. M. Hardwick-Smith S. , Response to a Letter to the Editor, “Ring Block for Neonatal Circumcision,” Obstetrics and Gynecology 92, no. 5 (1998): 892.

See Hardwick-Smith , supra note 44.

See Brady-Fryer , supra note 75; see Mastrobattista and Hardwick-Smith , supra note 87; Taddio A. Koren G. , “Lidocaine-Prilocaine Cream for Pain during Circumcision [reply],” New England Journal of Medicine 337, no. 8 (1997): 569–570; Taddio A. Koren G. , Response to a Letter to the Editor, “The Pediatric Forum: Is Research on Newborn Circumcision Ethical?” Archives of Pediatrics & Adolescent Medicine 155, no. 5 (2001): 618.

Somerville M. A. Alwin D. M. , “Lidocaine-Prilocaine Cream for Pain during Circumcision,” New England Journal of Medicine 337, no. 8 (1997): 568.

See Hill , supra note 54.

See Taddio Koren , supra note 55.

See Gunnar (1981), Gunnar (1984), Gunnar (1985), Gunnar (1988), and Talbert , supra note 66.

Van Howe R. S. , “Pain Relief for Neonatal Circumcision: Serious Design Flaws?” Pediatrics 103, no. 1 (1999): 196.

Bulter-O'Hara M. LeMoine C. Guillet R. , Response to a Letter to the Editor, “Pain Relief for Neonatal Circumcision: Serious Design Flaws?” Pediatrics 103, no. 1 (1999): 197.

See Baker , supra notes 3 and Baker , supra note 4.

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See Poland , supra note 36.

See Cold , supra note 32.

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Goldman R. , Questioning Circumcision: A Jewish Perspective (Boston: Vanguard Publications, 1998).

See supra note 24.

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Taylor J. R. Lockwood A. P. Taylor A. J. , “The Prepuce: Specialized Mucosa of the Penis and Its Loss to Circumcision,” British Journal of Urology 77, no. 2 (1996): 291–295; Cold C. J. Taylor J. , “The Prepuce,” BJU International 83, Supplement 1 (1999): 34–44.

See Svoboda , supra note 30.

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Taddio A. Pollock N. Gilbert-MacLeod C. , “Combined Analgesia and Local Anesthesia to Minimize Pain during Circumcision,” Archives of Pediatrics & Adolescent Medicine 154, no. 6 (2000): 620–623.

See Howard , supra note 23.

Stang H. J. Snellman L. W. Condon L. M. , “Beyond Dorsal Penile Nerve Block: A More Humane Circumcision,” Pediatrics 100, no. 2 (1997): e3.

Taeusch H. W. Martinez A. M. Partridge J. C. , “Pain during Mogen or PlastiBell Circumcision,” Journal of Perinatology 22, no. 3 (2002): 214–218.

See Anand Hickey , supra note 6.

Moses S. Bailey R. C. Ronald A. R. , “Male Circumcision: Assessment of Health Benefits and Risks,” Sexually Transmitted Infections 74, no. 5 (1998): 368–373.

See Herschel , supra note 23.

Holliday M. A. Pinckert T. L. Kiernan S. C. , “Dorsal Penile Nerve Block vs Topical Placebo for Circumcision in Low-Birth-Weight Neonates,” Archives of Pediatrics & Adolescent Medicine 153, no. 5 (1999): 476–480.

See Lander , supra note 23.

See Holton , supra note 69.

See Williamson , supra note 70.

See Butler-O'Hara , supra note 23.

Woodman P. J. , “Topical Lidocaine-prilocaine Versus Lidocaine for Neonatal Circumcision: A Randomized Controlled Trial,” Obstetrics and Gynecology 93, no. 5, Part 1 (1999): 775–779.

See Taddio , supra note 22.

See Hardwick-Smith , supra note 44.

See Mohan , supra note 29.

See Kurtis , supra note 46.

See Kass Holman , supra note 47.