EMLA - Revision history

WikiAdmin: using template LanderJ etal 1997

2024-03-09T10:19:36Z

using template LanderJ etal 1997

@@ Line 43: / Line 43: @@
   |date=2005
   |accessdate=2023-11-24
-}}</ref> EMLA® was the least-effective of the three analgesia methods studied.<ref name="lander1997">{{REFjournal
+}}</ref> EMLA® was the least-effective of the three analgesia methods studied.<ref name="lander1997">{{LanderJ etal 1997}}</ref>
 Before the specification of the approval in 2013, EMLA® ointment was often used in the so-called ''off-label use''<ref>{{REFweb
@@ Line 247: / Line 211: @@
   |accessdate=2020-12-21
 }}</ref>
 {{SEEALSO}}
 * [[Pain]]
 {{REF}}
 [[Category:Acronym]]

WikiModEn2: /* History */ Add author link.

2024-03-08T15:08:12Z

History: Add author link.

← Older revision		Revision as of 15:08, 8 March 2024
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	\|init=J		\|init=J
	\|first=Janice		\|first=Janice
	\|author-link=		\|author-link=Janice Lander
	\|last2=Brady-Frerer		\|last2=Brady-Frerer
	\|init2=B		\|init2=B

WikiModEn2: Revise citations.

2023-12-02T02:52:28Z

Revise citations.

← Older revision		Revision as of 02:52, 2 December 2023
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	}}</ref>		}}</ref>

	The conclusion of various studies show that the effectiveness of EMLA® is not sufficient to exclude the [[pain]] of non-therapeutic infant [[circumcision]].<ref>{{REFjournal		The conclusion of various studies show that the effectiveness of EMLA® is not sufficient to exclude the [[pain]] of non-therapeutic infant [[circumcision]].<ref name="lander1997" /> <ref>{{REFjournal
	\|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials		\|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials
	\|url=https://www.researchgate.net/publication/267728942		\|url=https://www.researchgate.net/publication/267728942
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	\|DOI=10.1136/emermed-2014-204066		\|DOI=10.1136/emermed-2014-204066
	\|accessdate=2020-12-19		\|accessdate=2020-12-19
	}}</ref><ref>{{REFjournal		}}</ref> <ref>{{REFjournal
	\|url=https://pubmed.ncbi.nlm.nih.gov/30587535/		\|url=https://pubmed.ncbi.nlm.nih.gov/30587535/
	\|title=Efficacy and Safety of EMLA Cream for Pain Control Due to Venipuncture in Infants: A Meta-analysis		\|title=Efficacy and Safety of EMLA Cream for Pain Control Due to Venipuncture in Infants: A Meta-analysis

WikiModEn2: /* History */ Revise sentence for clarity.

2023-12-02T02:48:19Z

History: Revise sentence for clarity.

← Older revision		Revision as of 02:48, 2 December 2023
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	}}</ref>		}}</ref>

	~~Various~~ studies ~~come to~~ the ~~conclusion that EMLA-circumcisions~~ of ~~young children are~~ not ~~suitable~~ to ~~sufficiently~~ exclude the [[pain]].<ref>{{REFjournal		The conclusion of various studies show that the effectiveness of EMLA® is not sufficient to exclude the [[pain]] of non-therapeutic infant [[circumcision]].<ref>{{REFjournal
	\|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials		\|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials
	\|url=https://www.researchgate.net/publication/267728942		\|url=https://www.researchgate.net/publication/267728942

WikiModEn2: /* Not approved for circumcision in newborns */

2023-12-01T23:01:25Z

Not approved for circumcision in newborns

← Older revision		Revision as of 23:01, 1 December 2023
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	== Not approved for circumcision in newborns ==		== Not approved for circumcision in newborns ==
	In July 2013, the German Federal Institute for Drugs and Medical Devices (BfArM) revoked the ''indication'' of the anesthetic ointment ~~EMLA~~ for circumcision of newborns.<ref>{{REFweb		In July 2013, the German Federal Institute for Drugs and Medical Devices (BfArM) revoked the ''indication'' of the anesthetic ointment EMLA® for [[circumcision]] of newborns.<ref>{{REFweb
	\|url=https://de.wikipedia.org/wiki/Zirkumzision#Schmerzen_und_postoperative_Beschwerden		\|url=https://de.wikipedia.org/wiki/Zirkumzision#Schmerzen_und_postoperative_Beschwerden
	\|title=Zirkumzision #Schmerzen und postoperative Beschwerden		\|title=Zirkumzision #Schmerzen und postoperative Beschwerden
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	\|date=2013-08-19		\|date=2013-08-19
	\|accessdate=2015-02-09		\|accessdate=2015-02-09
	}}</ref> ~~EMLA~~ has never had an ''approval'' for newborn circumcision, as the BfArM confirmed on March 7, 2013 to a medical member of [[Beschneidungsforum.de]]. The never-existing approval is evident from the technical information and instructions for use for ~~EMLA~~ and the drug law. The indications are under 4.1 of a technical and user information. Newborn circumcision was never performed there in Germany.<ref name="Wakankar 2014-02-19">{{REFweb		}}</ref> EMLA® has never had an ''approval'' for newborn [[circumcision]], as the BfArM confirmed on March 7, 2013 to a medical member of [[Beschneidungsforum.de]]. The never-existing approval is evident from the technical information and instructions for use for EMLA® and the drug law. The indications are under 4.1 of a technical and user information. Newborn circumcision was never performed there in Germany.<ref name="Wakankar 2014-02-19">{{REFweb
	\|url=https://www.beschneidungsforum.de/thread/2353-buchver%C3%B6ffentlichung-mit-einem-beitrag-von-j%C3%A9r%C3%B4me-segal-herausgeber-prof-matthia/?postID=27541#post27541		\|url=https://www.beschneidungsforum.de/thread/2353-buchver%C3%B6ffentlichung-mit-einem-beitrag-von-j%C3%A9r%C3%B4me-segal-herausgeber-prof-matthia/?postID=27541#post27541
	\|title=Die Beschneidung von Jungen, ein trauriges Vermächtnis		\|title=Die Beschneidung von Jungen, ein trauriges Vermächtnis
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	}}</ref>		}}</ref>

	The German manufacturer of the ~~EMLA~~ ointment now confirms (at the latest since 2018) in the leaflet:		The German manufacturer of the EMLA® ointment now confirms (at the latest since 2018) in the leaflet:
	{{Citation		{{Citation
	\|Author=Aspen Germany GmbH		\|Author=Aspen Germany GmbH
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	[...]		[...]

	'''Do not use ~~EMLA~~ on the following skin areas:'''		'''Do not use EMLA® on the following skin areas:'''
	* Cuts, abrasions or wounds other than leg ulcers.		* Cuts, abrasions or wounds other than leg ulcers.
	* in areas with a rash or eczema.		* in areas with a rash or eczema.
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	=== Legal consequences ===		=== Legal consequences ===
	The [[German Circumcision Act]] of 2012 implemented a so-called [[Mohel]] clause in paragraph 2, which states that up to the end of the sixth month of life, a boy can also be [[circumcised]] by a non-medical practitioner, as long as he is "trained" for this form of genital mutilation. The [[Circumcision Debate]] of that time impressively proves that Jewish [[Mohel]]s and other Jewish advocates of [[circumcision]] for boys repeatedly referred to the ~~EMLA~~ ointment as an adequate pain treatment.		The [[German Circumcision Act]] of 2012 implemented a so-called [[Mohel]] clause in paragraph 2, which states that up to the end of the sixth month of life, a boy can also be [[circumcised]] by a non-medical practitioner, as long as he is "trained" for this form of genital mutilation. The [[Circumcision Debate]] of that time impressively proves that Jewish [[Mohel]]s and other Jewish advocates of [[circumcision]] for boys repeatedly referred to the EMLA® ointment as an adequate pain treatment.

	The clear definition now available, that EMLA ointment may not be used at all in this case, leads at least paragraph 2 of the [[German Circumcision Act]] ad absurdum. It should be even easier for the German Federal Constitutional Court, once it has to decide on the constitutionality of [[§ 1631d BGB]], to put an end to this "fault of the rule of law".<ref>{{REFnews		The clear definition now available, that EMLA ointment may not be used at all in this case, leads at least paragraph 2 of the [[German Circumcision Act]] ad absurdum. It should be even easier for the German Federal Constitutional Court, once it has to decide on the constitutionality of [[§ 1631d BGB]], to put an end to this "fault of the rule of law".<ref>{{REFnews

WikiModEn2: /* History */ Add text and citation.

2023-12-01T22:57:16Z

History: Add text and citation.

@@ Line 36: / Line 36: @@
 == History ==
-Before the specification of the approval in 2013, EMLA ointment was often used in the so-called ''off-label use''<ref>{{REFweb
+Lander et al. (1997) did a comparison study of EMLA® cream topical anesthetic.<ref>{{REFweb
   |url=https://en.wikipedia.org/wiki/Off-label_use
   |title=Off-Label use
   |website=Wikipedia
   |accessdate=2022-07-27
-}}</ref> in neonatal circumcision. In addition, EMLA ointment does not require a prescription and can therefore be purchased over the counter. As a result, a medical risk assessment for off-label use is not guaranteed. Even less can it be assumed that the partly non-physician group of people who use EMLA® ointment for newborn circumcision recognizes the symptoms of toxic drug levels in the newborn, let alone masters them.<ref name="Wakankar 2014-02-18">{{REFweb
+}}</ref> in neonatal circumcision. In addition, EMLA® ointment does not require a prescription and can therefore be purchased over the counter. As a result, a medical risk assessment for off-label use is not guaranteed. Even less can it be assumed that the partly non-physician group of people who use EMLA® ointment for newborn circumcision recognizes the symptoms of toxic drug levels in the newborn, let alone masters them.<ref name="Wakankar 2014-02-18">{{REFweb
   |url=https://www.beschneidungsforum.de/thread/2353-buchver%C3%B6ffentlichung-mit-einem-beitrag-von-j%C3%A9r%C3%B4me-segal-herausgeber-prof-matthia/?postID=27504#post27504
   |title=Die Beschneidung von Jungen, ein trauriges Vermächtnis

WikiModEn2: /* Legal consequences */ Wikify

2023-11-30T23:46:15Z

Legal consequences: Wikify

← Older revision		Revision as of 23:46, 30 November 2023
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	=== Legal consequences ===		=== Legal consequences ===
	The [[German Circumcision Act]] of 2012 implemented a so-called [[Mohel]] clause in paragraph 2, which states that up to the end of the sixth month of life, a boy can also be circumcised by a non-medical practitioner, as long as he is "trained" for this form of genital mutilation. The [[Circumcision Debate]] of that time impressively proves that Jewish [[Mohel]]s and other Jewish advocates of [[circumcision]] for boys repeatedly referred to the EMLA ointment as an adequate pain treatment.		The [[German Circumcision Act]] of 2012 implemented a so-called [[Mohel]] clause in paragraph 2, which states that up to the end of the sixth month of life, a boy can also be [[circumcised]] by a non-medical practitioner, as long as he is "trained" for this form of genital mutilation. The [[Circumcision Debate]] of that time impressively proves that Jewish [[Mohel]]s and other Jewish advocates of [[circumcision]] for boys repeatedly referred to the EMLA ointment as an adequate pain treatment.

	The clear definition now available, that EMLA ointment may not be used at all in this case, leads at least paragraph 2 of the [[German Circumcision Act]] ad absurdum. It should be even easier for the German Federal Constitutional Court, once it has to decide on the constitutionality of [[§ 1631d BGB]], to put an end to this "fault of the rule of law".<ref>{{REFnews		The clear definition now available, that EMLA ointment may not be used at all in this case, leads at least paragraph 2 of the [[German Circumcision Act]] ad absurdum. It should be even easier for the German Federal Constitutional Court, once it has to decide on the constitutionality of [[§ 1631d BGB]], to put an end to this "fault of the rule of law".<ref>{{REFnews

WikiModEn2: Revise text and add citations.

2023-11-30T23:44:26Z

Revise text and add citations.

@@ Line 1: / Line 1: @@
-'''EMLA''' ointment is a local anesthetic.
+'''EMLA''' is an acronym for Eutectic Mixture of Local Anesthetic.<ref>{{REFweb
-The combination of lidocaine with the anesthetic prilocaine in a ratio of 1:1 creates an eutectic mixture (“Eutectic Mixture of Local Anesthetic”, EMLA) which is liquid at skin temperature and has good penetration into the skin.<ref>{{REFweb
+The combination of the topical anestheics lidocaine and prilocaine in a ratio of 1:1 creates an eutectic mixture (“Eutectic Mixture of Local Anesthetic”, EMLA) which is liquid at skin temperature and has good penetration into the skin.<ref>{{REFweb
   |url=https://en.wikipedia.org/wiki/Lidocaine#Local_numbing_agent
   |title=Lidocaine #Local numbing agent
   |website=Wikipedia
   |accessdate=2022-07-27
 }}</ref>

WikiModEn2: Add categories.

2023-11-30T23:03:29Z

Add categories.

← Older revision		Revision as of 23:03, 30 November 2023
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	{{REF}}		{{REF}}


			[[Category:Acronym]]
	[[Category:Medicine]]		[[Category:Medicine]]
	[[Category:Circumcision product]]		[[Category:Circumcision product]]
			[[Category:Pain]]
	[[de:EMLA]]		[[de:EMLA]]

WikiModEn2: Wikify.

2022-07-30T12:44:12Z

Wikify.

← Older revision		Revision as of 12:44, 30 July 2022
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	}}</ref>		}}</ref>

	In June 2013, the use of EMLA® ointment in neonatal circumcision was deemed “ethically unacceptable” by the CMDh group at the EMA.<ref>{{REFweb		In June 2013, the use of EMLA® ointment in neonatal [[circumcision]] was deemed “ethically unacceptable” by the CMDh group at the EMA.<ref>{{REFweb
	\|url=http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Lidocaine_2013_07_45_PdAR.pdf		\|url=http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Lidocaine_2013_07_45_PdAR.pdf
	\|title=Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Cathejell Lidocaine, Dynexan, EMLA, Jelliproct, Orofar, Strepsil lus, Xylestesin-A, Xylonor (Lidocaine)		\|title=Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Cathejell Lidocaine, Dynexan, EMLA, Jelliproct, Orofar, Strepsil lus, Xylestesin-A, Xylonor (Lidocaine)
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	}}</ref>		}}</ref>

	Various studies come to the conclusion that EMLA-circumcisions of young children are not suitable to sufficiently exclude the pain.<ref>{{REFjournal		Various studies come to the conclusion that EMLA-circumcisions of young children are not suitable to sufficiently exclude the [[pain]].<ref>{{REFjournal
	\|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials		\|title=Does topical Amethocaine cream increase first-Time successful cannulation in children compared with a eutectic mixture of local anaesthetics (EMLA) cream? A systematic review and meta-analysis of randomised controlled trials
	\|url=https://www.researchgate.net/publication/267728942		\|url=https://www.researchgate.net/publication/267728942