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  |date=2005
  |date=2005
  |accessdate=2023-11-24
  |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>
|last=Lander
|init=J
|first=Janice
|author-link=
|last2=Brady-Frerer
|init2=B
|first2=Barbara
|author2-link=
|last3=Metcalfe
|init3=JB
|first3=James B.
|author3-link=
|last4=Nazerali
|init4=S
|first4=Shermin
|author4-link=
|last5=Muttit
|init5=S
|first5=Sarah
|author5-link=
|etal=no
|title= Comparison of ring block, dorsal penile nerve block, and topical anesthesia for neonatal circumcision
|journal=JAMA
|location=
|date=1997-12-24
|volume=278
|issue=24
|pages=2157-64
|url=http://www.cirp.org/library/pain/lander/
|archived=
|quote=
|pubmedID=9417009
|pubmedCID=
|DOI=
|accessdate=2023-12-01
}}</ref>


Before the specification of the approval in 2013, EMLA® ointment was often used in the so-called ''off-label use''<ref>{{REFweb
Before the specification of the approval in 2013, EMLA® ointment was often used in the so-called ''off-label use''<ref>{{REFweb
Line 113: Line 77:
}}</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 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
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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
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  |accessdate=2020-12-21
  |accessdate=2020-12-21
}}</ref>
}}</ref>
{{SEEALSO}}
{{SEEALSO}}
* [[Pain]]
* [[Pain]]


{{REF}}
{{REF}}


[[Category:Acronym]]
[[Category:Acronym]]
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