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Easing Botox administration with EMLA cream
Clinical Insights
Easing Botox Administration With EMLA Cream
The author’s study demonstrates that application of EMLA cream to treatment sites significantly reduces needle pain during Botox administration. Twenty patients receiving 200 Botox injections in the glabellar area experienced a 60% reduction in pain in EMLApretreated sites compared with that in matched control sites. (Aesthetic Surg J 2004;24:79-81)
U
S Food and Drug Administration approval and widespread use of botulinum toxin A (Botox) for cosmetic facial applications has heralded a new era of nonsurgical office procedures. This injectable facial animation inhibitor, which is a valuable adjunct to surgical rejuvenation, is exceedingly effective and rapidly administered. Because Botox requires percutaneous injection to reach desired muscle sites, patients may experience some pain and apprehension.1 Injections are frequently administered in the forehead and around the eyes, so some patients experience more sensitivity and anxiety than they do with injections in other facial or bodily areas. I evaluated the use of a topical anesthetic cream, Eutetic Mixture Local Anesthetics (EMLA) (Astra
Pharmaceuticals, Westborough, MA), in reducing the discomfort of Botox injections. Patient Selection Twenty patients who had been previously treated with Botox forehead injections were selected as study subjects. Previously treated patients were chosen because they were more likely to have lower anxiety levels and could better evaluate injection pain. Patients reviewed and signed consent for study participation.
Treatments Ten glabellar injections to the procerus and corrugator muscles were administered in each patient in a standard pattern. Five injection sites on 1 side of the face were pretreated with EMLA cream; 5 injection sites on the other side of the face were pretreated with a similar-
AESTHETIC
appearing nonanesthetic cream, Kinerase (ICN Pharmaceuticals, Costa Mesa, CA). Patients were not told which side was being treated with the anesthetic cream. The topical agents were applied in a Barry L. Eppley, MD, simple “spot” method at Indianapolis, IN, is a board-cerinjection sites without the tified plastic surgeon. use of an occlusive dressing (Figure). The creams were allowed to dry for 30 minutes (until clear) before injections were administered. A total of 0.05 mL of Botox (2.5 µ/0.1 mL) was instilled in each injection site. On the basis of the paired nature of the injections,
patients were asked to not only grade each injection site (pain vs no pain) but also to grade which side of the matched pair was more painful. I conducted data analysis by first comparing paired injection sites on the basis of mean improvement and also by using a paired sign test to determine which side was less painful in each patient. Results Twenty patients receiving 200 injections were evaluated. On the left (control) side, 11 of 100 injections sites (11%; mean = 1.2, SD = .39) were rated as painless. On the right (experimental) side, 73 of 100 injection sites (73%; mean = 6.8, SD = .31) were rated as painless. When comparing the pain between the 2 sides (rather than at each injection site), all 20 patients (100%) reported a significant difference in pain control between the 2 sides, with the experimental side always better than the control side (P < .0001).
EMLA vs Alternatives EMLA is a well-accepted topical anesthetic cream that has been used for diverse skin applications, including venipuncture and superficial surgery. This eutectic mixture of 2.5% lidocaine and 2.5% prilocaine (pH 9) pro-
SURGERY
JOURNAL
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january/February
2004
79
Clinical Insights
A
B
Figure. A, Spot application of EMLA to injection sites. B, Absorption of EMLA after 30 minutes, with blanching of skin.
duces cutaneous anesthesia through dermal penetration. The depth of the dermal anesthetic effect increases in
accordance with how long the cream has been on the skin: After 60 minutes it is about 1 to 2 mm, and after 3 to 4 hours it may increase to 6 mm.2,3 Although a longer wait after application may offer greater dermal anesthesia, I chose 30 minutes as a practical interval for office administration. This was also the amount of time in which the creams lost their visibility through absorption and evaporation. Applied with a spot-application technique, EMLA cream is effective in improving the discomfort of Botox injections. Its effectiveness has been previously demonstrated in eyelid injections, although the application method was different. 4 Applying a dot of EMLA cream at the site of a skin injection is easy, convenient, and inexpensive. A 5-g tube will likely provide enough cream for more than 25 patients. Many other methods of decreasing the pain of Botox injections have been proposed. Using the smallest-gauge needle5 is an obvious intervention that, combined with a small-volume syringe, also helps ensure accurate administration. Although EMLA is traditionally used with occlusion when administered in larger volumes, the findings of this study demonstrate that occlusion is not necessary, particularly in injections with small-gauge needles. Reconstitution with an isotonic mixing solution (preservative-containing saline solution) and lowering of skin temperature with the use of various cooling methods (eg, ice, aerosol sprays) have also been shown to decrease injection discomfort.6,7 However, ice, in particular, is inconve-
80
Aesthetic
Surgery
Journal
~
nient to apply, and the pain control it affords is only partially effective.8 Other topical anesthetic preparations are available — among them ELA-Max (4% liposomal lidocaine; Ferndale Laboratories, Inc., Ferndale, MI); 4% tetracaine gel, and betacaine-local anesthesia ointment, but none of these has clearly demonstrated pain control superior to that of EMLA. That they are similar in effectiveness to EMLA for this application can be inferred but not proved with these findings.9-11 Conclusion The use of EMLA cream is a rapid and effective method of decreasing pain during the percutaneous administration of Botox for aesthetic facial enhancement. Pain is reduced by more than 60% when EMLA is applied 30 minutes before treatment. Although injection pain is not eliminated, discomfort is clearly diminished. This finding will improve the acceptance of such intramuscular treatments, particularly in the apprehensive patient.
References 1. Yazuver R, Demirtas Y. Painful injections with botox. Plast Reconstr Surg 2003;111: 509-510. 2. Friedman PM, Mafong EA, Friedman ES, Geronemus RG. Topical anesthetics update: EMLA and beyond. Dermatol Surg 2001;27:10191026. 3. Wahlgreen CF, Quiding H. Depth of cutaneous analgesia after application of a eutectic mixture of the local anesthetics lidocaine and prilocaine (EMLA cream). J Am Acad Dermatol 2000;42:584-588. 4. Soylev MF, Kocak N, Kuvaki B, Ozkan SB, Kir E. Anesthesia with EMLA cream for botulinum A toxin injection into eyelids. Ophthalmologica 2002;216:355-358.
january/February
2004
Volume 24, Number 1
Clinical Insights
5. Flynn TC, Carruthers A, Carruthers J. Surgical pearl: the use of the Ultra-Fine II short needle 0.3-cc insulin syringe for botulinum toxin injections. J Am Acad Dermatol 2002;46:931-932.
10. Koppel RA, Coleman KM, Coleman WP. The efficacy of EMLA versus ELA-Max for pain relief in medium-depth chemical peeling: a clinical and histopathologic evaluation. Dermatol Surg 2000;26:61-64.
6. Alam M, Dover JS, Arndt KA. Pain associated with injection of botulinum A exotoxin reconstituted using isotonic sodium chloride with and without preservative: a double-blind randomized controlled trial. Arch Dermatol 2002;138:510-514.
11. Eichenfield LF, Funk A, Fallon-Friedlander S, Cunningham BB. A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics 2002;109:1093-1099.
7. Linder JS, Edmonson BC, Laquis SJ, Drewry RD Jr, Fleming JC. Skin cooling before periocular botulinum toxin A injection. Ophthal Plast Reconstr Surg 2002;18:441-442. 8. Kuwahara RT, Skinner RB. EMLA versus ice as a topical anesthetic. Dermatol Surg 2001;27:495. 9. Friedman PM, Fogelman JP, Nouri K, Levine VJ, Ashinoff R. Comparative study of the efficacy of four topical anesthetics. Dermatol Surg 1999;25:950-954.
Easing Botox Administration With EMLA Cream
AESTHETIC
Reprint requests: Barry l. Eppley, MD, Indiana University School of medicine, 702 Barnhill Drive # 3540, Indianapolis, Indiana 46202. 1090-820X/$30.00 Copyright ©2004 by The American Society for Aesthetic Plastic Surgery, Inc. doi:10.1016/j.asj.2003.10
SURGERY
JOURNAL
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january/February
2004
81
Easing Botox Administration With EMLA Cream
The author’s study demonstrates that application of EMLA cream to treatment sites significantly reduces needle pain during Botox administration. Twenty patients receiving 200 Botox injections in the glabellar area experienced a 60% reduction in pain in EMLApretreated sites compared with that in matched control sites. (Aesthetic Surg J 2004;24:79-81)
U
S Food and Drug Administration approval and widespread use of botulinum toxin A (Botox) for cosmetic facial applications has heralded a new era of nonsurgical office procedures. This injectable facial animation inhibitor, which is a valuable adjunct to surgical rejuvenation, is exceedingly effective and rapidly administered. Because Botox requires percutaneous injection to reach desired muscle sites, patients may experience some pain and apprehension.1 Injections are frequently administered in the forehead and around the eyes, so some patients experience more sensitivity and anxiety than they do with injections in other facial or bodily areas. I evaluated the use of a topical anesthetic cream, Eutetic Mixture Local Anesthetics (EMLA) (Astra
Pharmaceuticals, Westborough, MA), in reducing the discomfort of Botox injections. Patient Selection Twenty patients who had been previously treated with Botox forehead injections were selected as study subjects. Previously treated patients were chosen because they were more likely to have lower anxiety levels and could better evaluate injection pain. Patients reviewed and signed consent for study participation.
Treatments Ten glabellar injections to the procerus and corrugator muscles were administered in each patient in a standard pattern. Five injection sites on 1 side of the face were pretreated with EMLA cream; 5 injection sites on the other side of the face were pretreated with a similar-
AESTHETIC
appearing nonanesthetic cream, Kinerase (ICN Pharmaceuticals, Costa Mesa, CA). Patients were not told which side was being treated with the anesthetic cream. The topical agents were applied in a Barry L. Eppley, MD, simple “spot” method at Indianapolis, IN, is a board-cerinjection sites without the tified plastic surgeon. use of an occlusive dressing (Figure). The creams were allowed to dry for 30 minutes (until clear) before injections were administered. A total of 0.05 mL of Botox (2.5 µ/0.1 mL) was instilled in each injection site. On the basis of the paired nature of the injections,
patients were asked to not only grade each injection site (pain vs no pain) but also to grade which side of the matched pair was more painful. I conducted data analysis by first comparing paired injection sites on the basis of mean improvement and also by using a paired sign test to determine which side was less painful in each patient. Results Twenty patients receiving 200 injections were evaluated. On the left (control) side, 11 of 100 injections sites (11%; mean = 1.2, SD = .39) were rated as painless. On the right (experimental) side, 73 of 100 injection sites (73%; mean = 6.8, SD = .31) were rated as painless. When comparing the pain between the 2 sides (rather than at each injection site), all 20 patients (100%) reported a significant difference in pain control between the 2 sides, with the experimental side always better than the control side (P < .0001).
EMLA vs Alternatives EMLA is a well-accepted topical anesthetic cream that has been used for diverse skin applications, including venipuncture and superficial surgery. This eutectic mixture of 2.5% lidocaine and 2.5% prilocaine (pH 9) pro-
SURGERY
JOURNAL
~
january/February
2004
79
Clinical Insights
A
B
Figure. A, Spot application of EMLA to injection sites. B, Absorption of EMLA after 30 minutes, with blanching of skin.
duces cutaneous anesthesia through dermal penetration. The depth of the dermal anesthetic effect increases in
accordance with how long the cream has been on the skin: After 60 minutes it is about 1 to 2 mm, and after 3 to 4 hours it may increase to 6 mm.2,3 Although a longer wait after application may offer greater dermal anesthesia, I chose 30 minutes as a practical interval for office administration. This was also the amount of time in which the creams lost their visibility through absorption and evaporation. Applied with a spot-application technique, EMLA cream is effective in improving the discomfort of Botox injections. Its effectiveness has been previously demonstrated in eyelid injections, although the application method was different. 4 Applying a dot of EMLA cream at the site of a skin injection is easy, convenient, and inexpensive. A 5-g tube will likely provide enough cream for more than 25 patients. Many other methods of decreasing the pain of Botox injections have been proposed. Using the smallest-gauge needle5 is an obvious intervention that, combined with a small-volume syringe, also helps ensure accurate administration. Although EMLA is traditionally used with occlusion when administered in larger volumes, the findings of this study demonstrate that occlusion is not necessary, particularly in injections with small-gauge needles. Reconstitution with an isotonic mixing solution (preservative-containing saline solution) and lowering of skin temperature with the use of various cooling methods (eg, ice, aerosol sprays) have also been shown to decrease injection discomfort.6,7 However, ice, in particular, is inconve-
80
Aesthetic
Surgery
Journal
~
nient to apply, and the pain control it affords is only partially effective.8 Other topical anesthetic preparations are available — among them ELA-Max (4% liposomal lidocaine; Ferndale Laboratories, Inc., Ferndale, MI); 4% tetracaine gel, and betacaine-local anesthesia ointment, but none of these has clearly demonstrated pain control superior to that of EMLA. That they are similar in effectiveness to EMLA for this application can be inferred but not proved with these findings.9-11 Conclusion The use of EMLA cream is a rapid and effective method of decreasing pain during the percutaneous administration of Botox for aesthetic facial enhancement. Pain is reduced by more than 60% when EMLA is applied 30 minutes before treatment. Although injection pain is not eliminated, discomfort is clearly diminished. This finding will improve the acceptance of such intramuscular treatments, particularly in the apprehensive patient.
References 1. Yazuver R, Demirtas Y. Painful injections with botox. Plast Reconstr Surg 2003;111: 509-510. 2. Friedman PM, Mafong EA, Friedman ES, Geronemus RG. Topical anesthetics update: EMLA and beyond. Dermatol Surg 2001;27:10191026. 3. Wahlgreen CF, Quiding H. Depth of cutaneous analgesia after application of a eutectic mixture of the local anesthetics lidocaine and prilocaine (EMLA cream). J Am Acad Dermatol 2000;42:584-588. 4. Soylev MF, Kocak N, Kuvaki B, Ozkan SB, Kir E. Anesthesia with EMLA cream for botulinum A toxin injection into eyelids. Ophthalmologica 2002;216:355-358.
january/February
2004
Volume 24, Number 1
Clinical Insights
5. Flynn TC, Carruthers A, Carruthers J. Surgical pearl: the use of the Ultra-Fine II short needle 0.3-cc insulin syringe for botulinum toxin injections. J Am Acad Dermatol 2002;46:931-932.
10. Koppel RA, Coleman KM, Coleman WP. The efficacy of EMLA versus ELA-Max for pain relief in medium-depth chemical peeling: a clinical and histopathologic evaluation. Dermatol Surg 2000;26:61-64.
6. Alam M, Dover JS, Arndt KA. Pain associated with injection of botulinum A exotoxin reconstituted using isotonic sodium chloride with and without preservative: a double-blind randomized controlled trial. Arch Dermatol 2002;138:510-514.
11. Eichenfield LF, Funk A, Fallon-Friedlander S, Cunningham BB. A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics 2002;109:1093-1099.
7. Linder JS, Edmonson BC, Laquis SJ, Drewry RD Jr, Fleming JC. Skin cooling before periocular botulinum toxin A injection. Ophthal Plast Reconstr Surg 2002;18:441-442. 8. Kuwahara RT, Skinner RB. EMLA versus ice as a topical anesthetic. Dermatol Surg 2001;27:495. 9. Friedman PM, Fogelman JP, Nouri K, Levine VJ, Ashinoff R. Comparative study of the efficacy of four topical anesthetics. Dermatol Surg 1999;25:950-954.
Easing Botox Administration With EMLA Cream
AESTHETIC
Reprint requests: Barry l. Eppley, MD, Indiana University School of medicine, 702 Barnhill Drive # 3540, Indianapolis, Indiana 46202. 1090-820X/$30.00 Copyright ©2004 by The American Society for Aesthetic Plastic Surgery, Inc. doi:10.1016/j.asj.2003.10
SURGERY
JOURNAL
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january/February
2004
81