| Accelerated Reversal of Soft-Tissue Anesthesia in Children | ||
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S.M. GORDON1, J. CHAN2, J. CHIN3, A. HENEGAR4, J. KLEVEN5, J.M. MAILHOT6, A.S. PAPAS7, D. STUDEN-PAVLOVICH8, J.L. PFAIL9, T. RAYBOULD10, M. TAVARES11, L.A. NAVALTA12, S. ROGY12, and R.B. RUTHERFORD12, 1University of Maryland Dental School, Baltimore, USA, 2Pediatric practice, El Cajon, CA, USA, 3Indiana University School of Dentistry, Indianapolis, USA, 4North Hills Medical Research Inc, Irving, TX, USA, 5North Hills Medical Research, Bedford, TX, USA, 6Marquette University, Milwaukee, WI, USA, 7Tufts University, Boston, MA, USA, 8University of Pittsburgh, PA, USA, 9The Mount Sinai Hospital, New York, NY, USA, 10University of Kentucky, Lexington, USA, 11Forsyth Institute, Boston, MA, USA, 12Novalar Pharmaceuticals, Inc, San Diego, CA, USA Objectives: The objective of this Phase 2 study of pediatric patients (n=152, 4-11 y/o) was to evaluate the safety and efficacy of a new proprietary formulation of phentolamine mesylate (PM), a short-term, nonspecific alpha-adrenergic blocker and vasodilator, as an anesthetic reversal agent. The hypothesis that local maxillary or mandibular injections of PM would shorten the duration of unwanted soft tissue anesthesia (STA) after routine local oral anesthesia was tested. The prolonged duration of STA can lead to accidental lip, cheek and tongue biting among children. Methods: Eligible subjects received local anesthesia using standard clinical techniques and anesthetics containing a vasoconstrictor preceding routine dental restorative or periodontal maintenance procedures. Following completion of the procedure, subjects with STA were randomized to receive PM or control (sham injection) in a 2:1 allocation ratio, respectively, stratified according to the location of the dental procedure (mandible or maxilla) and study site. PM was injected into the same site(s) as the local anesthetic. Subjects who weighed >/=15 to < 30 kg received 0.2 mg; those >/=30 kg received 0.2 or 0.4 mg. The duration of STA was measured by a standardized lip tapping procedure. Results: PM reduced the median time required for recovery from STA in the lip by 75 minutes (55.6%) compared with sham injection (p<0.0001). PM was well tolerated with no serious adverse events (AEs). No patients were discontinued due to AEs. AEs were equally distributed between the randomly assigned treatment groups and resolved within the study period. No drug effect on pain or vital signs was detected. Conclusions: PM safely accelerates reversal of STA in children following routine clinical procedures. PM has the potential to improve the oral health of children through ameliorating unwanted consequences of local anesthetics. Sponsored by Novalar Pharmaceuticals, Inc., San Diego, CA, USA | ||
| Seq #0 - Late Breaking News - Session I 9:00 AM-10:30 AM, Thursday, March 22, 2007 Ernest N. Morial Convention Center 287 | ||
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