title: Phase Four, Randomized, Double-Blinded, Controlled Trial of Phentolamine Mesylate in Two- to Five-year-old Dental Patients.
abstract: OBJECTIVE
  The purpose of this study was to evaluate, using a randomized, double-blind methodology: (1) the safety of phentolamine mesylate (Oraverse) in accelerating the recovery of soft tissue anesthesia following the injection of two percent lidocaine plus 1:100,000 epinephrine in two- to five-year-olds; and (2) efficacy in four- to five-year-olds only.
  
  
  METHODS
  One hundred fifty pediatric dental patients underwent routine dental restorative procedures with two percent lidocaine plus 1:100,000 epinephrine with doses based on body weight. Phentolamine mesylate or a sham injection (two to one ratio) was then administered. Subjects were monitored for safety and, in four- to five-year-olds, for efficacy during the two-hour evaluation period.
  
  
  RESULTS
  There were no significant differences in adverse events between the phentolamine and sham injections. Compared to sham, phentolamine was not associated with nerve injury, increased analgesic use, or abnormalities of the oral cavity. Phentolamine was associated with transient decreased blood pressure in some children. In four- and five-year-olds, phentolamine induced more rapid recovery of lip anesthesia by 48 minutes (P<0.0001).
  
  
  CONCLUSIONS
  Phentolamine was well tolerated and safe in three- to five-year-olds; in four- to five-year-olds, a statistically significant more rapid recovery of lip sensation compared to sham injections was determined.
authors.affiliation: Professor of pharmacology and division director of pharmacology and therapeutics, Department of Oral Surgery and Pharmacology, in the School of Dental Medicine, University of Pennsylvania, Philadelphia, Pa., USA;, Email: evhersh@upenn.edu.
authors.forename: Elliot V
authors.initials: EV
authors.lastname: Hersh
authors.affiliation: Associate professor of pediatric dentistry, Department of Preventive and Restorative Sciences, in the School of Dental Medicine, University of Pennsylvania, Philadelphia, Pa., USA.
authors.forename: Rochelle
authors.initials: R
authors.lastname: Lindemeyer
authors.affiliation: Professor of pediatric dentistry, Lloyd and Kay Chapman Chair for Oral Health, and dean, University of Washington School of Dentistry, Seattle, Wash., USA.
authors.forename: Joel H
authors.initials: JH
authors.lastname: Berg
authors.affiliation: Professor of pediatric dentistry, Division of Pediatric Dentistry, School of Dentistry, The Ohio State University, Columbus, Ohio, USA.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Casamassimo
authors.affiliation: Professor of pediatric dentistry, Department of Pediatric Dentistry, College of Dental Medicine, Nova Southeastern University, Fort Lauderdale, Fla., USA.
authors.forename: Judith
authors.initials: J
authors.lastname: Chin
authors.affiliation: Clinical director for dental research, Jean Brown Research; and is in private practice, Salt Lake City, Utah, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Marberger
authors.affiliation: Clinical professor of pediatric dentistry and director of predoctoral pediatric dentistry, University of California School of Dentistry, San Francisco, Calif., USA.
authors.forename: Brent P
authors.initials: BP
authors.lastname: Lin
authors.affiliation: Founder and a partner, Tegra Analytics, Doylestown, Pa., USA.
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Hutcheson
authors.affiliation: Professor of pharmacology, dental anesthesiology, and dental public health, School of Dental Medicine, University of Pittsburgh, Pittsburgh, Pa., USA.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Moore
authors.forename: Pediatric Soft Tissue Anesthesia Recovery
authors.initials: PS
authors.lastname: Group
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000762:Anesthesia Recovery Period; D000766:Anesthesia, Dental / Q000379:methods*; D002675:Child, Preschool; D019140:Dental Care for Children / Q000379:methods; D003793:Dental Restoration, Permanent / Q000379:methods; D004311:Double-Blind Method; D004837:Epinephrine / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D010646:Phentolamine / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000317:Adrenergic alpha-Antagonists; D008012:Lidocaine; D004837:Epinephrine; D010646:Phentolamine