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 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.
  
  
  CONCLUSIONS
  Clinicians can use PM to accelerate reversal of soft-tissue anesthesia and the associated functional deficits.
authors.affiliation: Oral and Maxillofacial Surgery and Pharmacology, School of Dental Medicine, University of Pennsylvania, 240 S. 40th Street, Philadelphia, PA 19104, USA. evhersh@pobox.upenn.edu
authors.forename: Elliot V
authors.initials: EV
authors.lastname: Hersh
authors.forename: Paul A
authors.initials: PA
authors.lastname: Moore
authors.forename: Athena S
authors.initials: AS
authors.lastname: Papas
authors.forename: J Max
authors.initials: JM
authors.lastname: Goodson
authors.forename: Laura A
authors.initials: LA
authors.lastname: Navalta
authors.forename: Siegfried
authors.initials: S
authors.lastname: Rogy
authors.forename: Bruce
authors.initials: B
authors.lastname: Rutherford
authors.forename: John A
authors.initials: JA
authors.lastname: Yagiela
mesh_terms: D000293:Adolescent; D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D000766:Anesthesia, Dental; D000779:Anesthetics, Local / Q000037:antagonists & inhibitors*; D002355:Carticaine / Q000037:antagonists & inhibitors; D002648:Child; D003793:Dental Restoration, Permanent; D012534:Dental Scaling; D004837:Epinephrine / Q000037:antagonists & inhibitors; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000037:antagonists & inhibitors; D008046:Lip / Q000187:drug effects / Q000502:physiology; D008297:Male; D008619:Mepivacaine / Q000037:antagonists & inhibitors; D008875:Middle Aged; D008771:Nordefrin / Q000037:antagonists & inhibitors; D010646:Phentolamine / Q000627:therapeutic use*; D011318:Prilocaine / Q000037:antagonists & inhibitors; D012449:Safety; D012677:Sensation / Q000187:drug effects / Q000502:physiology; D013997:Time Factors; D014059:Tongue / Q000187:drug effects / Q000502:physiology; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000037:antagonists & inhibitors
chemical_list: D000317:Adrenergic alpha-Antagonists; D000779:Anesthetics, Local; D014662:Vasoconstrictor Agents; D011318:Prilocaine; D008012:Lidocaine; D008619:Mepivacaine; D002355:Carticaine; D008771:Nordefrin; D004837:Epinephrine; D010646:Phentolamine