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

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)1080-1093
Number of pages14
JournalJournal of the American Dental Association
Volume139
Issue number8
StatePublished - Aug 2008

Fingerprint

Phentolamine
Local Anesthesia
Lip
Local Anesthetics
Tongue
Anesthesia
Injections
Safety
Phase III Clinical Trials
Hypesthesia
Controlled Clinical Trials
Vasoconstrictor Agents
Needles
Tooth
Research Personnel

Keywords

  • Articaine
  • Epinephrine
  • Levonordefrin
  • Lidocaine
  • Local anesthesia
  • Mepivacaine
  • Phentolamine mesylate
  • Prilocaine

ASJC Scopus subject areas

  • Dentistry(all)

Cite this

Hersh, E. V., Moore, P. A., Papas, A. S., Goodson, J. M., Mavalta, L. A., Rogy, S., ... 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.

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

In: Journal of the American Dental Association, Vol. 139, No. 8, 08.2008, p. 1080-1093.

Research output: Contribution to journalArticle

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.
Hersh EV, Moore PA, Papas AS, Goodson JM, Mavalta LA, Rogy S et al. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. Journal of the American Dental Association. 2008 Aug;139(8):1080-1093.
Hersh, Elliot V. ; Moore, Paul A. ; Papas, Athena S. ; Goodson, J. Max ; Mavalta, Laura A. ; Rogy, Siegfried ; Rutherford, Bruce ; Yagiela, John A. ; Bennett, Jeffrey ; Eggertsson, Hafsteinn ; Jarrett, Jodie L. ; Mau, Melissa S. ; Boynes, Sean G. ; Lemak, Anne L. ; Zovko, Jayme G. ; Krzesinski, Maribeth ; Aboosi, O. Basil ; Pinto, Andres ; Secreto, Stacey A. ; Gallagher, Bridget ; Rosenberg, Morton ; Singh, Mabi ; Pradhan, Nooruddin Sadruddin ; Singh, Medha ; Raybould, Ted P. ; Pfail, John L. ; Valauri, David V. ; Ivanova, Yordanka K. ; Gordon, Sharon M. ; Arribas, Alfredo ; Sankar, Vidya ; Luce, Ernest B. ; Valdez, Ernest E. ; Gonzales, Noemi C. ; Henegar, Anthony ; Schreiber, Andrea ; Allen, Kenneth ; Lopresti, James ; Kreismann, Judith ; Andrew, Margaret ; Freer, George A. ; McGavin, Scott Kelsey ; Blissett, Georgia ; McCallister, Pauline ; Smith, Jodi ; Beales, Kim ; Giannobile, William V. ; Kim, Amy S. ; Snyder, Mark D. ; Snow, Paul R. ; Luo, Steven Y. ; Robinson, Amanda ; Peralta, Steffany ; Hudson, Michelle ; Kleven, Jacqueline ; Tavares, Mary ; Soncini, Jennifer ; Chvetchkova, Maria ; Roberts, Christine ; Murray, Lora ; Stultz, Jacyn ; Floros, Constantinos C. ; Hayashi, Christine M. ; Torres, Indira ; Parisi, Melinda ; Goss, Jennifer S. ; Shiba, Deborah. / Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. In: Journal of the American Dental Association. 2008 ; Vol. 139, No. 8. pp. 1080-1093.
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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",
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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

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

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M3 - Article

VL - 139

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EP - 1093

JO - Journal of the American Dental Association

JF - Journal of the American Dental Association

SN - 0002-8177

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