drugset / Trial / NCT05448807

Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children

NCT05448807

Phase 3 Recruiting 100 enrolled Cairo University
RandomizedParallel-groupDouble-blindSupportive care

Summary

Local anaesthesia is considered one of the most alarming and non-comfortable dental procedures for children. This goes back to the persisting effect of the local anaesthesia after finishing dental procedures. The effect of Local anaesthesia can last from 3 to 5 hours due to the presence of vasoconstrictor. The U.S Food and Drug Administration (FDA approved the use of phentolamine mesylate (Oraverse) in May 2008 to be used as a drug in reversing the numbing effect of Local anaesthesia by decreasing the time needed to restore the normal functions of the mouth

Timeline

Start
2025-07-05
Primary completion
2026-04-20
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Phentolamine Small molecule 0.4 mg Other

Indications

No indication recorded.