EMLA: Difference between revisions
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'''EMLA''' | '''EMLA''' is an acronym for Eutectic Mixture of Local Anesthetic.<ref>{{REFweb | ||
|url=https://medical-dictionary.thefreedictionary.com/EMLA | |||
|title=EMLA | |||
|last=Anonymous | |||
|first= | |||
|init= | |||
|publisher=The Free Dictionary by Farlex. | |||
|date=2008 | |||
|accessdate=2023-11-30 | |||
}}</ref> EMLA Cream is a trademarked brand of topical local anesthetic. ''Eutectic'' means that the melting point of the combination is less than that of the ingredients.<ref>{{REFweb | |||
|url=https://en.wikipedia.org/wiki/Eutectic_system | |||
|title=Eutectic system | |||
|last= | |||
|first= | |||
|init= | |||
|publisher=Wiipedia | |||
|date= | |||
|accessdate=2023-11-30 | |||
}}</ref> | |||
The combination of lidocaine | 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 | |url=https://en.wikipedia.org/wiki/Lidocaine#Local_numbing_agent | ||
|title=Lidocaine #Local numbing agent | |title=Lidocaine #Local numbing agent | ||
|website=Wikipedia | |website=Wikipedia | ||
|accessdate=2022-07-27 | |accessdate=2022-07-27 | ||
}}</ref> EMLA Cream is used to numb local areas of skin.<ref>{{REFweb | |||
|url=https://www.drugs.com/emla.html | |||
|title=Emla Cream | |||
|last= | |||
|first= | |||
|init= | |||
|publisher=Drugs.com | |||
|date= | |||
|accessdate=2023-11-30 | |||
}}</ref> | }}</ref> | ||
== History == | == History == | ||
Before the specification of the approval in 2013, | 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® ointment was often used in the so-called ''off-label use''<ref>{{REFweb | |||
|url=https://en.wikipedia.org/wiki/Off-label_use | |url=https://en.wikipedia.org/wiki/Off-label_use | ||
|title=Off-Label use | |title=Off-Label use | ||
|website=Wikipedia | |website=Wikipedia | ||
|accessdate=2022-07-27 | |accessdate=2022-07-27 | ||
}}</ref> in neonatal circumcision. In addition, | }}</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 | |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 | |title=Die Beschneidung von Jungen, ein trauriges Vermächtnis | ||
| Line 41: | Line 77: | ||
}}</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 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 | 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> | }}</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 | 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 | '''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 | 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]] | ||