drugset / Trial / NCT01474382
Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
Timeline
- Start
- 2012-02
- Primary completion
- 2014-08
- Completion
- 2014-08
Publications
- Background Hersh EV, Moore PA, Papas AS, Goodson JM, Navalta LA, Rogy S, Rutherford B, Yagiela JA; Soft Tissue Anesthesia Recovery Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. J Am Dent Assoc. 2008 Aug;139(8):1080-93. doi: 10.14219/jada.archive.2008.0311.
- Background Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog. 2008 Summer;55(2):40-8. doi: 10.2344/0003-3006(2008)55[40:POLWEF]2.0.CO;2.
- Background Tavares M, Goodson JM, Studen-Pavlovich D, Yagiela JA, Navalta LA, Rogy S, Rutherford B, Gordon S, Papas AS; Soft Tissue Anesthesia Reversal Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. J Am Dent Assoc. 2008 Aug;139(8):1095-104. doi: 10.14219/jada.archive.2008.0312.
- Background Laviola M, McGavin SK, Freer GA, Plancich G, Woodbury SC, Marinkovich S, Morrison R, Reader A, Rutherford RB, Yagiela JA. Randomized study of phentolamine mesylate for reversal of local anesthesia. J Dent Res. 2008 Jul;87(7):635-9. doi: 10.1177/154405910808700717.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Phentolamine | Small molecule | 0.45 ml | — |
| Subject | Phentolamine | Small molecule | 0.9 ml | — |
| Subject | Phentolamine | Small molecule | 1.8 ml | — |
Indications
No indication recorded.