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Open Access Phase Four, Randomized, Double-Blinded, Controlled Trial of Phentolamine Mesylate in Two- to Five-year-old Dental Patients

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Purpose: 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.
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Keywords: LIDOCAINE; LOCAL ANESTHESIA; PHENTOLAMINE MESYLATE; RANDOMIZED CONTROLLED CLINICAL TRIAL

Document Type: Research Article

Affiliations: 1: 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: [email protected] 2: Associate professor of pediatric dentistry, Department of Preventive and Restorative Sciences, in the School of Dental Medicine, University of Pennsylvania, Philadelphia, Pa., USA 3: Professor of pediatric dentistry, Lloyd and Kay Chapman Chair for Oral Health, and dean, University of Washington School of Dentistry, Seattle, Wash., USA 4: Professor of pediatric dentistry, Division of Pediatric Dentistry, School of Dentistry, The Ohio State University, Columbus, Ohio, USA 5: Professor of pediatric dentistry, Department of Pediatric Dentistry, College of Dental Medicine, Nova Southeastern University, Fort Lauderdale, Fla., USA 6: Clinical director for dental research, Jean Brown Research; and is in private practice, Salt Lake City, Utah, USA 7: Clinical professor of pediatric dentistry and director of predoctoral pediatric dentistry, University of California School of Dentistry, San Francisco, Calif., USA 8: Founder and a partner, Tegra Analytics, Doylestown, Pa., USA 9: Professor of pharmacology, dental anesthesiology, and dental public health, School of Dental Medicine, University of Pittsburgh, Pittsburgh, Pa., USA

Publication date: January 1, 2017

More about this publication?
  • Pediatric Dentistry is the official publication of the American Academy of Pediatric Dentistry, the American Board of Pediatric Dentistry and the College of Diplomates of the American Board of Pediatric Dentistry. It is published bi-monthly and is internationally recognized as the leading journal in the area of pediatric dentistry. The journal promotes the practice, education and research specifically related to the specialty of pediatric dentistry. This peer-reviewed journal features scientific articles, case reports and abstracts of current pediatric dental research.
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