Reversal of Soft-Tissue Local Anesthesia With Phentolamine Mesylate in Adolescents and Adults

• Published in: The Journal of the American Dental Association (1939) Vol. 139; no. 8; pp. 1080 - 1093
• Main Authors: Hersh, Elliot V., DMD, MS, PhD, Moore, Paul A., DMD, PhD, MPH, Papas, Athena S., DMD, PhD, Goodson, J. Max, DDS, PhD, Navalta, Laura A., BA, Rogy, Siegfried, PhD, Rutherford, Bruce, DDS, PhD, Yagiela, John A., DDS, PhD
• Format: Journal Article
• Language: English
• Published: England Elsevier Inc 01-08-2008; Am Dental Assoc; American Dental Association
• Subjects: Adolescent; Adrenergic alpha-Antagonists - therapeutic use; Adult; Adults; Aged; Anesthesia; Anesthesia Recovery Period; Anesthesia, Dental; Anesthetics, Local - antagonists & inhibitors; articaine; Carticaine - antagonists & inhibitors; Child; Clinical outcomes; Clinical trials; Dental Restoration, Permanent; Dental Scaling; Dentistry; Drug therapy; epinephrine; Epinephrine - antagonists & inhibitors; Female; Humans; levonordefrin; lidocaine; Lidocaine - antagonists & inhibitors; Lip - drug effects; Lip - physiology; Local anesthesia; Male; mepivacaine; Mepivacaine - antagonists & inhibitors; Middle Aged; Nordefrin - antagonists & inhibitors; Patient safety; Phentolamine - therapeutic use; phentolamine mesylate; prilocaine; Prilocaine - antagonists & inhibitors; Safety; Sensation - drug effects; Sensation - physiology; Teenagers; Time Factors; Tongue - drug effects; Tongue - physiology; Treatment Outcome; Vasoconstrictor Agents - antagonists & inhibitors; Soft Tissue Anesthesia Recovery; levonordefrin; FDA; phentolamine mesylate; articaine; Heft-Parker visual analog scale; IVRS; Principal investigator; lidocaine; AEs; AFT; Accelerated failure time; Functional Assessment Battery; Adverse events; Interactive voice response system; FAB; U.S. Food and Drug Administration; epinephrine; mepivacaine; H-P VAS; STAR; Local anesthesia; PI; prilocaine; PM
• ISSN: 0002-8177; 1943-4723
• DOI: 10.14219/jada.archive.2008.0311

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 lip 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.