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Cosmetic Clinic

Numbing Alternatives

January 2008

As if the prospect of an election year isn’t numbing enough, once the campaign season kicks into high gear, the droning speeches and endless commercials will put many of us under as surely as general anesthesia.

However, campaign speech-induced anesthesia is generally not what physicians have in mind when seeking to ensure a comfortable experience for themselves and their patients undergoing a cosmetic procedure.
 

Patient Comfort — Not a Luxury

Patient comfort should not be underestimated as a critical facet of any cosmetic procedure, whether it is an injection of a botulinum toxin or filler or a treatment with a fractional resurfacing laser.

A painful experience is stressful for both physician and patient. A patient who likens your techniques to waterboarding will neither return nor send referrals. As for the physician, it is difficult to obtain a great technical injection while feeling pressure to simply complete the procedure on a patient who is clearly miserable and too agitated to remain still during the injections.
 

What’s Out There

The alternatives that are available now include some that are entirely new as well as others that are not but that may have newer methods of administration. They include topical preparations and injections as well as a few novel treatments.

This discussion will focus on the options in topical anesthesia, especially the advantages and disadvantages of prepared and compounded product, each of which has benefits and deficiencies.
 

Compounded Topicals

Most of my friends in the aesthetic community have taken to compounding products that have different concentrations of both amides and esters, that is tetracaine, benzocaine, prilocaine and/or lidocaine.

Typical compounded products are applied for anywhere from 15 to 60 minutes, and they may be used with or without occlusion.

Of the products compounded, two that have gained popularity include: 20% benzocaine, 8% lidocaine and 4% tetracaine; and 7% to 8% each of lidocaine and prilocaine. When applied, these topical anesthetics produce a mild to moderate anesthesia in about 15 to 30 minutes. Permutations of these formulae are also available.
 

Special Considerations Regarding Compounded Products

Problems associated with the use of compounded topicals, which are not approved by the FDA, usually concern their increased potential for toxicity or allergies due to variability of concentrations, as well as liability associated with their lack of FDA approval.

Variability of Formulations

Unlike products that have been approved by the FDA, there is variability of the formulations depending on the pharmacy that produces the product and the level of experience and ability of the pharmacist who fills the order.

Variability in some compounding pharmacies has resulted in a host of problems ranging from ineffective concentrations to those that are potentially harmful. A few documented deaths have been associated with the use of these agents (none associated with a dermatologist).

Toxicity

Toxicity from topical anesthetics may result in seizures and respiratory distress. If this does not instill a healthy respect for these topical medications, there have also been case reports of methemoglobinemia following administration of topical anesthetics in both pediatric and adult patients.

Liability

Therefore, whatever their origin or source, compounded products may be associated with liability issues regarding various state and federal regulations.

Avoiding Product Toxicity

The toxic quantity required depends on the concentrations of the anesthetics contained so, unlike a 1% lidocaine with 1:100k of epinephrine injection, the amounts of product that are safe to use are somewhat variable and depend upon the compounding pharmacy.

Avoiding product toxicity requires a knowledge of the recommended maximal amounts (not easily obtained for some of the products) and the mathematical ability to convert the concentrations (often given as a percentage) to mg/kg. This latter point may sound trivial, but if asked, most of your colleagues will need to refer to a textbook for the proper conversions.

Toxic levels of the various anesthetics may be reached by applying large quantities of the drugs onto large areas of the body.

For Prilocaine, the reported toxic level for dental use is 6 mg/kg. Lidocaine dosing should be limited to 3 mg/kg to 5 mg/kg when administered without epinephrine and 7 mg/kg when administered with epinephrine. The liposuction literature has demonstrated safety of this with doses as high as 35 mg/kg to 40 mg/kg, but this is for tumescent fluids administered into the adipose layer.
 

Non Compounded Products

Non compounded products — LMX 4 and 5, EMLA, and now Pliaglis — offer the safety of having been certified by the FDA as safe and effective. In addition, there are no issues as with compounded products regarding distribution, crossing state lines by ordering from another state, or variability in manufactured concentrations.

For Pliaglis, EMLA, Topicaine and LMX, no data exist regarding toxicity and information about how much is allowable.

Topicaine, a 4% or 5% lidocaine gel, is available from ESBA pharmacy (https://www.topicaine.com). The 5% product is for anorectal use, but this should not be a deterrent for using it on the face.

LMX 4 and LMX 5 are good products that may be safely used. Patients can apply these prior to coming to the office, and these anesthetics have a good efficacy profile. They are helpful for laser hair removal as well as for some types of injection such as botulinum toxins, particularly for reliable patients, who can apply the products 1 hour prior to their treatments. They are limited by their low concentrations.

EMLA was the first topical medication approved for use as a topical anesthetic, and it still enjoys some limited use. However, it has largely been supplanted by more effective products. Its chief benefit is that it is safe and somewhat effective and it may be covered by the patient’s insurance plan.

The most recent addition to topical anesthetics is Pliaglis, which I consider the first advance in topical anesthesia in a long time. (I was skeptical about using this product until Pat Wexler applied some to my face, and in about 30 minutes she could have pulled my teeth and I would have thanked her.)

I have started using this product for some Botox injections and for Fraxel treatments. While it does not provide total anesthesia, it offers enough that my patients have been very appreciative of the difference. Its benefits include the fact that it forms a sheet that can be easily peeled.
 

Creating Pleasure, Not Pain

Anesthesia may make the difference between a happy cosmetic patient who returns for additional treatments and one who considers the prospect of a visit to your office a form of rendition.

The topical alternatives differ dramatically in their safety and efficacy. Compounded products offer the attraction of higher concentrations and the ability to formulate products that have specific ingredients. FDA-approved products offer the comfort of a process that has evaluated the product for safety and efficacy. Each has its own benefits and it is worthwhile considering these, as well as their risks, before using them in your practice.

Dr. Beer is in private practice in West Palm Beach, FL. He’s also Volunteer Clinical Instructor in Dermatology at the University of Miami, a Consulting Associate in the Department of Medicine at Duke University, and Director of The Cosmetic Boot Camp meeting.

 

 

As if the prospect of an election year isn’t numbing enough, once the campaign season kicks into high gear, the droning speeches and endless commercials will put many of us under as surely as general anesthesia.

However, campaign speech-induced anesthesia is generally not what physicians have in mind when seeking to ensure a comfortable experience for themselves and their patients undergoing a cosmetic procedure.
 

Patient Comfort — Not a Luxury

Patient comfort should not be underestimated as a critical facet of any cosmetic procedure, whether it is an injection of a botulinum toxin or filler or a treatment with a fractional resurfacing laser.

A painful experience is stressful for both physician and patient. A patient who likens your techniques to waterboarding will neither return nor send referrals. As for the physician, it is difficult to obtain a great technical injection while feeling pressure to simply complete the procedure on a patient who is clearly miserable and too agitated to remain still during the injections.
 

What’s Out There

The alternatives that are available now include some that are entirely new as well as others that are not but that may have newer methods of administration. They include topical preparations and injections as well as a few novel treatments.

This discussion will focus on the options in topical anesthesia, especially the advantages and disadvantages of prepared and compounded product, each of which has benefits and deficiencies.
 

Compounded Topicals

Most of my friends in the aesthetic community have taken to compounding products that have different concentrations of both amides and esters, that is tetracaine, benzocaine, prilocaine and/or lidocaine.

Typical compounded products are applied for anywhere from 15 to 60 minutes, and they may be used with or without occlusion.

Of the products compounded, two that have gained popularity include: 20% benzocaine, 8% lidocaine and 4% tetracaine; and 7% to 8% each of lidocaine and prilocaine. When applied, these topical anesthetics produce a mild to moderate anesthesia in about 15 to 30 minutes. Permutations of these formulae are also available.
 

Special Considerations Regarding Compounded Products

Problems associated with the use of compounded topicals, which are not approved by the FDA, usually concern their increased potential for toxicity or allergies due to variability of concentrations, as well as liability associated with their lack of FDA approval.

Variability of Formulations

Unlike products that have been approved by the FDA, there is variability of the formulations depending on the pharmacy that produces the product and the level of experience and ability of the pharmacist who fills the order.

Variability in some compounding pharmacies has resulted in a host of problems ranging from ineffective concentrations to those that are potentially harmful. A few documented deaths have been associated with the use of these agents (none associated with a dermatologist).

Toxicity

Toxicity from topical anesthetics may result in seizures and respiratory distress. If this does not instill a healthy respect for these topical medications, there have also been case reports of methemoglobinemia following administration of topical anesthetics in both pediatric and adult patients.

Liability

Therefore, whatever their origin or source, compounded products may be associated with liability issues regarding various state and federal regulations.

Avoiding Product Toxicity

The toxic quantity required depends on the concentrations of the anesthetics contained so, unlike a 1% lidocaine with 1:100k of epinephrine injection, the amounts of product that are safe to use are somewhat variable and depend upon the compounding pharmacy.

Avoiding product toxicity requires a knowledge of the recommended maximal amounts (not easily obtained for some of the products) and the mathematical ability to convert the concentrations (often given as a percentage) to mg/kg. This latter point may sound trivial, but if asked, most of your colleagues will need to refer to a textbook for the proper conversions.

Toxic levels of the various anesthetics may be reached by applying large quantities of the drugs onto large areas of the body.

For Prilocaine, the reported toxic level for dental use is 6 mg/kg. Lidocaine dosing should be limited to 3 mg/kg to 5 mg/kg when administered without epinephrine and 7 mg/kg when administered with epinephrine. The liposuction literature has demonstrated safety of this with doses as high as 35 mg/kg to 40 mg/kg, but this is for tumescent fluids administered into the adipose layer.
 

Non Compounded Products

Non compounded products — LMX 4 and 5, EMLA, and now Pliaglis — offer the safety of having been certified by the FDA as safe and effective. In addition, there are no issues as with compounded products regarding distribution, crossing state lines by ordering from another state, or variability in manufactured concentrations.

For Pliaglis, EMLA, Topicaine and LMX, no data exist regarding toxicity and information about how much is allowable.

Topicaine, a 4% or 5% lidocaine gel, is available from ESBA pharmacy (https://www.topicaine.com). The 5% product is for anorectal use, but this should not be a deterrent for using it on the face.

LMX 4 and LMX 5 are good products that may be safely used. Patients can apply these prior to coming to the office, and these anesthetics have a good efficacy profile. They are helpful for laser hair removal as well as for some types of injection such as botulinum toxins, particularly for reliable patients, who can apply the products 1 hour prior to their treatments. They are limited by their low concentrations.

EMLA was the first topical medication approved for use as a topical anesthetic, and it still enjoys some limited use. However, it has largely been supplanted by more effective products. Its chief benefit is that it is safe and somewhat effective and it may be covered by the patient’s insurance plan.

The most recent addition to topical anesthetics is Pliaglis, which I consider the first advance in topical anesthesia in a long time. (I was skeptical about using this product until Pat Wexler applied some to my face, and in about 30 minutes she could have pulled my teeth and I would have thanked her.)

I have started using this product for some Botox injections and for Fraxel treatments. While it does not provide total anesthesia, it offers enough that my patients have been very appreciative of the difference. Its benefits include the fact that it forms a sheet that can be easily peeled.
 

Creating Pleasure, Not Pain

Anesthesia may make the difference between a happy cosmetic patient who returns for additional treatments and one who considers the prospect of a visit to your office a form of rendition.

The topical alternatives differ dramatically in their safety and efficacy. Compounded products offer the attraction of higher concentrations and the ability to formulate products that have specific ingredients. FDA-approved products offer the comfort of a process that has evaluated the product for safety and efficacy. Each has its own benefits and it is worthwhile considering these, as well as their risks, before using them in your practice.

Dr. Beer is in private practice in West Palm Beach, FL. He’s also Volunteer Clinical Instructor in Dermatology at the University of Miami, a Consulting Associate in the Department of Medicine at Duke University, and Director of The Cosmetic Boot Camp meeting.

 

 

As if the prospect of an election year isn’t numbing enough, once the campaign season kicks into high gear, the droning speeches and endless commercials will put many of us under as surely as general anesthesia.

However, campaign speech-induced anesthesia is generally not what physicians have in mind when seeking to ensure a comfortable experience for themselves and their patients undergoing a cosmetic procedure.
 

Patient Comfort — Not a Luxury

Patient comfort should not be underestimated as a critical facet of any cosmetic procedure, whether it is an injection of a botulinum toxin or filler or a treatment with a fractional resurfacing laser.

A painful experience is stressful for both physician and patient. A patient who likens your techniques to waterboarding will neither return nor send referrals. As for the physician, it is difficult to obtain a great technical injection while feeling pressure to simply complete the procedure on a patient who is clearly miserable and too agitated to remain still during the injections.
 

What’s Out There

The alternatives that are available now include some that are entirely new as well as others that are not but that may have newer methods of administration. They include topical preparations and injections as well as a few novel treatments.

This discussion will focus on the options in topical anesthesia, especially the advantages and disadvantages of prepared and compounded product, each of which has benefits and deficiencies.
 

Compounded Topicals

Most of my friends in the aesthetic community have taken to compounding products that have different concentrations of both amides and esters, that is tetracaine, benzocaine, prilocaine and/or lidocaine.

Typical compounded products are applied for anywhere from 15 to 60 minutes, and they may be used with or without occlusion.

Of the products compounded, two that have gained popularity include: 20% benzocaine, 8% lidocaine and 4% tetracaine; and 7% to 8% each of lidocaine and prilocaine. When applied, these topical anesthetics produce a mild to moderate anesthesia in about 15 to 30 minutes. Permutations of these formulae are also available.
 

Special Considerations Regarding Compounded Products

Problems associated with the use of compounded topicals, which are not approved by the FDA, usually concern their increased potential for toxicity or allergies due to variability of concentrations, as well as liability associated with their lack of FDA approval.

Variability of Formulations

Unlike products that have been approved by the FDA, there is variability of the formulations depending on the pharmacy that produces the product and the level of experience and ability of the pharmacist who fills the order.

Variability in some compounding pharmacies has resulted in a host of problems ranging from ineffective concentrations to those that are potentially harmful. A few documented deaths have been associated with the use of these agents (none associated with a dermatologist).

Toxicity

Toxicity from topical anesthetics may result in seizures and respiratory distress. If this does not instill a healthy respect for these topical medications, there have also been case reports of methemoglobinemia following administration of topical anesthetics in both pediatric and adult patients.

Liability

Therefore, whatever their origin or source, compounded products may be associated with liability issues regarding various state and federal regulations.

Avoiding Product Toxicity

The toxic quantity required depends on the concentrations of the anesthetics contained so, unlike a 1% lidocaine with 1:100k of epinephrine injection, the amounts of product that are safe to use are somewhat variable and depend upon the compounding pharmacy.

Avoiding product toxicity requires a knowledge of the recommended maximal amounts (not easily obtained for some of the products) and the mathematical ability to convert the concentrations (often given as a percentage) to mg/kg. This latter point may sound trivial, but if asked, most of your colleagues will need to refer to a textbook for the proper conversions.

Toxic levels of the various anesthetics may be reached by applying large quantities of the drugs onto large areas of the body.

For Prilocaine, the reported toxic level for dental use is 6 mg/kg. Lidocaine dosing should be limited to 3 mg/kg to 5 mg/kg when administered without epinephrine and 7 mg/kg when administered with epinephrine. The liposuction literature has demonstrated safety of this with doses as high as 35 mg/kg to 40 mg/kg, but this is for tumescent fluids administered into the adipose layer.
 

Non Compounded Products

Non compounded products — LMX 4 and 5, EMLA, and now Pliaglis — offer the safety of having been certified by the FDA as safe and effective. In addition, there are no issues as with compounded products regarding distribution, crossing state lines by ordering from another state, or variability in manufactured concentrations.

For Pliaglis, EMLA, Topicaine and LMX, no data exist regarding toxicity and information about how much is allowable.

Topicaine, a 4% or 5% lidocaine gel, is available from ESBA pharmacy (https://www.topicaine.com). The 5% product is for anorectal use, but this should not be a deterrent for using it on the face.

LMX 4 and LMX 5 are good products that may be safely used. Patients can apply these prior to coming to the office, and these anesthetics have a good efficacy profile. They are helpful for laser hair removal as well as for some types of injection such as botulinum toxins, particularly for reliable patients, who can apply the products 1 hour prior to their treatments. They are limited by their low concentrations.

EMLA was the first topical medication approved for use as a topical anesthetic, and it still enjoys some limited use. However, it has largely been supplanted by more effective products. Its chief benefit is that it is safe and somewhat effective and it may be covered by the patient’s insurance plan.

The most recent addition to topical anesthetics is Pliaglis, which I consider the first advance in topical anesthesia in a long time. (I was skeptical about using this product until Pat Wexler applied some to my face, and in about 30 minutes she could have pulled my teeth and I would have thanked her.)

I have started using this product for some Botox injections and for Fraxel treatments. While it does not provide total anesthesia, it offers enough that my patients have been very appreciative of the difference. Its benefits include the fact that it forms a sheet that can be easily peeled.
 

Creating Pleasure, Not Pain

Anesthesia may make the difference between a happy cosmetic patient who returns for additional treatments and one who considers the prospect of a visit to your office a form of rendition.

The topical alternatives differ dramatically in their safety and efficacy. Compounded products offer the attraction of higher concentrations and the ability to formulate products that have specific ingredients. FDA-approved products offer the comfort of a process that has evaluated the product for safety and efficacy. Each has its own benefits and it is worthwhile considering these, as well as their risks, before using them in your practice.

Dr. Beer is in private practice in West Palm Beach, FL. He’s also Volunteer Clinical Instructor in Dermatology at the University of Miami, a Consulting Associate in the Department of Medicine at Duke University, and Director of The Cosmetic Boot Camp meeting.

 

 

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