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EMLA

481 bytes added, 9 March
using template LanderJ etal 1997
== History ==
Lander et al. (1997) did a comparison study of EMLA® cream topical anesthetic.<ref>{{REFweb |url=https://medical-dictionary.thefreedictionary.com/Emla+cream |title=Emla cream |last=Anonymous |publisher=The Free Dictionary by Farley |date=2005 |accessdate=2023-11-24}}</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 EMLA® ointment was often used in the so-called ''off-label use''<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 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
}}</ref>
Various The conclusion of various studies come to show that the conclusion that EMLA-circumcisions effectiveness of young children are EMLA® is not suitable sufficient to sufficiently 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
|url=https://www.researchgate.net/publication/267728942
|DOI=10.1136/emermed-2014-204066
|accessdate=2020-12-19
}}</ref><ref>{{REFjournal
|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
== 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 EMLA® for [[circumcision ]] of newborns.<ref>{{REFweb
|url=https://de.wikipedia.org/wiki/Zirkumzision#Schmerzen_und_postoperative_Beschwerden
|title=Zirkumzision #Schmerzen und postoperative Beschwerden
|date=2013-08-19
|accessdate=2015-02-09
}}</ref> EMLA 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 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
|title=Die Beschneidung von Jungen, ein trauriges Vermächtnis
}}</ref>
The German manufacturer of the EMLA EMLA® ointment now confirms (at the latest since 2018) in the leaflet:
{{Citation
|Author=Aspen Germany GmbH
[...]
'''Do not use EMLA EMLA® on the following skin areas:'''
* Cuts, abrasions or wounds other than leg ulcers.
* in areas with a rash or eczema.
=== 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 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
|accessdate=2020-12-21
}}</ref>
 
{{SEEALSO}}
* [[Pain]]
{{REF}}
 
[[Category:Acronym]]
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