Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults

Elliot V. Hersh; Paul A. Moore; Athena S. Papas; J. Max Goodson; Laura A. Mavalta; Siegfried Rogy; Bruce Rutherford; John A. Yagiela; Jeffrey Bennett; Hafsteinn Eggertsson; Jodie L. Jarrett; Melissa S. Mau; Sean G. Boynes; Anne L. Lemak; Jayme G. Zovko; Maribeth Krzesinski; O. Basil Aboosi; Andres Pinto; Stacey A. Secreto; Bridget Gallagher; Morton Rosenberg; Mabi Singh; Nooruddin Sadruddin Pradhan; Medha Singh; Ted P. Raybould; John L. Pfail; David V. Valauri; Yordanka K. Ivanova; Sharon M. Gordon; Alfredo Arribas; Vidya Sankar; Ernest B. Luce; Ernest E. Valdez; Noemi C. Gonzales; Anthony Henegar; Andrea Schreiber; Kenneth Allen; James LoPresti; Judith Kreismann; Margaret Andrew; George A. Freer; Scott Kelsey McGavin; Georgia Blissett; Pauline McCallister; Jodi Smith; Kim Beales; William V. Giannobile; Amy S. Kim; Mark D. Snyder; Paul R. Snow; Steven Y. Luo; Amanda Robinson; Steffany Peralta; Michelle Hudson; Jacqueline Kleven; Mary Tavares; Jennifer Soncini; Maria Chvetchkova; Christine Roberts; Lora Murray; Jacyn Stultz; Constantinos C. Floros; Christine M. Hayashi; Indira Torres; Melinda Parisi; Jennifer S. Goss; Deborah Shiba

doi:10.14219/jada.archive.2008.0311

Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults

Elliot V. Hersh, Paul A. Moore, Athena S. Papas, J. Max Goodson, Laura A. Mavalta, Siegfried Rogy, Bruce Rutherford, John A. Yagiela, Jeffrey Bennett, Hafsteinn Eggertsson, Jodie L. Jarrett, Melissa S. Mau, Sean G. Boynes, Anne L. Lemak, Jayme G. Zovko, Maribeth Krzesinski, O. Basil Aboosi, Andres Pinto, Stacey A. Secreto, Bridget GallagherMorton Rosenberg, Mabi Singh, Nooruddin Sadruddin Pradhan, Medha Singh, Ted P. Raybould, John L. Pfail, David V. Valauri, Yordanka K. Ivanova, Sharon M. Gordon, Alfredo Arribas, Vidya Sankar, Ernest B. Luce, Ernest E. Valdez, Noemi C. Gonzales, Anthony Henegar, Andrea Schreiber, Kenneth Allen, James LoPresti, Judith Kreismann, Margaret Andrew, George A. Freer, Scott Kelsey McGavin, Georgia Blissett, Pauline McCallister, Jodi Smith, Kim Beales, William V. Giannobile, Amy S. Kim, Mark D. Snyder, Paul R. Snow, Steven Y. Luo, Amanda Robinson, Steffany Peralta, Michelle Hudson, Jacqueline Kleven, Mary Tavares, Jennifer Soncini, Maria Chvetchkova, Christine Roberts, Lora Murray, Jacyn Stultz, Constantinos C. Floros, Christine M. Hayashi, Indira Torres, Melinda Parisi, Jennifer S. Goss, Deborah Shiba

Oral Health Science

Research output: Contribution to journal › Article › peer-review

48 Scopus citations

Abstract

Background. The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures. Methods. On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results. Median recovery times in the lower Hp and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant (P < .0001). Recovery from actual functional deficits and subject-perceived altered function, sensation and appearance also showed significant differences between the PM and the sham groups. Conclusions. PM was efficacious and safe in reducing the duration of local anesthetic-induced soft-tissue numbness and its associated functional deficits. Clinical Implications. Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.

Original language	English
Pages (from-to)	1080-1093
Number of pages	14
Journal	Journal of the American Dental Association
Volume	139
Issue number	8
DOIs	https://doi.org/10.14219/jada.archive.2008.0311
State	Published - Aug 2008

Bibliographical note

Funding Information:
This study was sponsored by Novalar Pharmaceuticals, San Diego.

Funding

This study was sponsored by Novalar Pharmaceuticals, San Diego.

Funders	Funder number
Novalar Pharmaceuticals
University of California San Diego Health

Keywords

Articaine
Epinephrine
Levonordefrin
Lidocaine
Local anesthesia
Mepivacaine
Phentolamine mesylate
Prilocaine

ASJC Scopus subject areas

General Dentistry

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10.14219/jada.archive.2008.0311

Cite this

Hersh, E. V., Moore, P. A., Papas, A. S., Goodson, J. M., Mavalta, L. A., Rogy, S., Rutherford, B., Yagiela, J. A., Bennett, J., Eggertsson, H., Jarrett, J. L., Mau, M. S., Boynes, S. G., Lemak, A. L., Zovko, J. G., Krzesinski, M., Aboosi, O. B., Pinto, A., Secreto, S. A., ... Shiba, D. (2008). Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. Journal of the American Dental Association, 139(8), 1080-1093. https://doi.org/10.14219/jada.archive.2008.0311

@article{cd0fe03b27714440a0c290d79ff4b4b3,

title = "Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults",

abstract = "Background. The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures. Methods. On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results. Median recovery times in the lower Hp and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant (P < .0001). Recovery from actual functional deficits and subject-perceived altered function, sensation and appearance also showed significant differences between the PM and the sham groups. Conclusions. PM was efficacious and safe in reducing the duration of local anesthetic-induced soft-tissue numbness and its associated functional deficits. Clinical Implications. Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.",

keywords = "Articaine, Epinephrine, Levonordefrin, Lidocaine, Local anesthesia, Mepivacaine, Phentolamine mesylate, Prilocaine",

author = "Hersh, {Elliot V.} and Moore, {Paul A.} and Papas, {Athena S.} and Goodson, {J. Max} and Mavalta, {Laura A.} and Siegfried Rogy and Bruce Rutherford and Yagiela, {John A.} and Jeffrey Bennett and Hafsteinn Eggertsson and Jarrett, {Jodie L.} and Mau, {Melissa S.} and Boynes, {Sean G.} and Lemak, {Anne L.} and Zovko, {Jayme G.} and Maribeth Krzesinski and Aboosi, {O. Basil} and Andres Pinto and Secreto, {Stacey A.} and Bridget Gallagher and Morton Rosenberg and Mabi Singh and Pradhan, {Nooruddin Sadruddin} and Medha Singh and Raybould, {Ted P.} and Pfail, {John L.} and Valauri, {David V.} and Ivanova, {Yordanka K.} and Gordon, {Sharon M.} and Alfredo Arribas and Vidya Sankar and Luce, {Ernest B.} and Valdez, {Ernest E.} and Gonzales, {Noemi C.} and Anthony Henegar and Andrea Schreiber and Kenneth Allen and James LoPresti and Judith Kreismann and Margaret Andrew and Freer, {George A.} and McGavin, {Scott Kelsey} and Georgia Blissett and Pauline McCallister and Jodi Smith and Kim Beales and Giannobile, {William V.} and Kim, {Amy S.} and Snyder, {Mark D.} and Snow, {Paul R.} and Luo, {Steven Y.} and Amanda Robinson and Steffany Peralta and Michelle Hudson and Jacqueline Kleven and Mary Tavares and Jennifer Soncini and Maria Chvetchkova and Christine Roberts and Lora Murray and Jacyn Stultz and Floros, {Constantinos C.} and Hayashi, {Christine M.} and Indira Torres and Melinda Parisi and Goss, {Jennifer S.} and Deborah Shiba",

note = "Funding Information: This study was sponsored by Novalar Pharmaceuticals, San Diego. ",

year = "2008",

month = aug,

doi = "10.14219/jada.archive.2008.0311",

language = "English",

volume = "139",

pages = "1080--1093",

number = "8",

}

Hersh, EV, Moore, PA, Papas, AS, Goodson, JM, Mavalta, LA, Rogy, S, Rutherford, B, Yagiela, JA, Bennett, J, Eggertsson, H, Jarrett, JL, Mau, MS, Boynes, SG, Lemak, AL, Zovko, JG, Krzesinski, M, Aboosi, OB, Pinto, A, Secreto, SA, Gallagher, B, Rosenberg, M, Singh, M, Pradhan, NS, Singh, M, Raybould, TP, Pfail, JL, Valauri, DV, Ivanova, YK, Gordon, SM, Arribas, A, Sankar, V, Luce, EB, Valdez, EE, Gonzales, NC, Henegar, A, Schreiber, A, Allen, K, LoPresti, J, Kreismann, J, Andrew, M, Freer, GA, McGavin, SK, Blissett, G, McCallister, P, Smith, J, Beales, K, Giannobile, WV, Kim, AS, Snyder, MD, Snow, PR, Luo, SY, Robinson, A, Peralta, S, Hudson, M, Kleven, J, Tavares, M, Soncini, J, Chvetchkova, M, Roberts, C, Murray, L, Stultz, J, Floros, CC, Hayashi, CM, Torres, I, Parisi, M, Goss, JS & Shiba, D 2008, 'Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults', Journal of the American Dental Association, vol. 139, no. 8, pp. 1080-1093. https://doi.org/10.14219/jada.archive.2008.0311

TY - JOUR

T1 - Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults

AU - Hersh, Elliot V.

AU - Moore, Paul A.

AU - Papas, Athena S.

AU - Goodson, J. Max

AU - Mavalta, Laura A.

AU - Rogy, Siegfried

AU - Rutherford, Bruce

AU - Yagiela, John A.

AU - Bennett, Jeffrey

AU - Eggertsson, Hafsteinn

AU - Jarrett, Jodie L.

AU - Mau, Melissa S.

AU - Boynes, Sean G.

AU - Lemak, Anne L.

AU - Zovko, Jayme G.

AU - Krzesinski, Maribeth

AU - Aboosi, O. Basil

AU - Pinto, Andres

AU - Secreto, Stacey A.

AU - Gallagher, Bridget

AU - Rosenberg, Morton

AU - Singh, Mabi

AU - Pradhan, Nooruddin Sadruddin

AU - Singh, Medha

AU - Raybould, Ted P.

AU - Pfail, John L.

AU - Valauri, David V.

AU - Ivanova, Yordanka K.

AU - Gordon, Sharon M.

AU - Arribas, Alfredo

AU - Sankar, Vidya

AU - Luce, Ernest B.

AU - Valdez, Ernest E.

AU - Gonzales, Noemi C.

AU - Henegar, Anthony

AU - Schreiber, Andrea

AU - Allen, Kenneth

AU - LoPresti, James

AU - Kreismann, Judith

AU - Andrew, Margaret

AU - Freer, George A.

AU - McGavin, Scott Kelsey

AU - Blissett, Georgia

AU - McCallister, Pauline

AU - Smith, Jodi

AU - Beales, Kim

AU - Giannobile, William V.

AU - Kim, Amy S.

AU - Snyder, Mark D.

AU - Snow, Paul R.

AU - Luo, Steven Y.

AU - Robinson, Amanda

AU - Peralta, Steffany

AU - Hudson, Michelle

AU - Kleven, Jacqueline

AU - Tavares, Mary

AU - Soncini, Jennifer

AU - Chvetchkova, Maria

AU - Roberts, Christine

AU - Murray, Lora

AU - Stultz, Jacyn

AU - Floros, Constantinos C.

AU - Hayashi, Christine M.

AU - Torres, Indira

AU - Parisi, Melinda

AU - Goss, Jennifer S.

AU - Shiba, Deborah

N1 - Funding Information: This study was sponsored by Novalar Pharmaceuticals, San Diego.

PY - 2008/8

Y1 - 2008/8

N2 - Background. The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures. Methods. On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results. Median recovery times in the lower Hp and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant (P < .0001). Recovery from actual functional deficits and subject-perceived altered function, sensation and appearance also showed significant differences between the PM and the sham groups. Conclusions. PM was efficacious and safe in reducing the duration of local anesthetic-induced soft-tissue numbness and its associated functional deficits. Clinical Implications. Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.

AB - Background. The authors conducted two multicenter, randomized, double-blinded, controlled Phase III clinical trials to study the efficacy and safety of phentolamine mesylate (PM) in shortening the duration and burden of soft-tissue anesthesia. The study involved 484 subjects who received one of four commercially available local anesthetic solutions containing vasoconstrictors for restorative or scaling procedures. Methods. On completion of the dental procedure, subjects randomly received a PM or a sham injection (an injection in which a needle does not penetrate the soft tissue) in the same site as the local anesthetic injection. The investigators measured the duration of soft-tissue anesthesia by using standardized lip- and tongue-tapping procedures every five minutes for five hours. They also evaluated functional measures and subject-perceived altered function, sensation, appearance and safety. Results. Median recovery times in the lower Hp and tongue for subjects in the PM group were 70 minutes and 60 minutes, respectively. Median recovery times in the lower lip and tongue for subjects in the sham group were 155 minutes and 125 minutes, respectively. Upper lip median recovery times were 50 minutes for subjects in the PM group and 133 minutes for subjects in the sham group. These differences were significant (P < .0001). Recovery from actual functional deficits and subject-perceived altered function, sensation and appearance also showed significant differences between the PM and the sham groups. Conclusions. PM was efficacious and safe in reducing the duration of local anesthetic-induced soft-tissue numbness and its associated functional deficits. Clinical Implications. Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.

KW - Articaine

KW - Epinephrine

KW - Levonordefrin

KW - Lidocaine

KW - Local anesthesia

KW - Mepivacaine

KW - Phentolamine mesylate

KW - Prilocaine

UR - http://www.scopus.com/inward/record.url?scp=52449123633&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=52449123633&partnerID=8YFLogxK

U2 - 10.14219/jada.archive.2008.0311

DO - 10.14219/jada.archive.2008.0311

M3 - Article

C2 - 18682623

AN - SCOPUS:52449123633

SN - 0002-8177

VL - 139

SP - 1080

EP - 1093

JO - Journal of the American Dental Association

JF - Journal of the American Dental Association

IS - 8

ER -

Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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