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RECRUITING
NCT05448807
PHASE3

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

Sponsor: Cairo University

View on ClinicalTrials.gov

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

Official title: A Randomized Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Decreasing Self- Inflicted Soft Tissue Trauma Following Local Anaesthesia Injection for Dental Procedure in Children: Randomized Clinical Trial

Key Details

Gender

All

Age Range

5 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07-05

Completion Date

2026-06

Last Updated

2025-07-10

Healthy Volunteers

Yes

Interventions

DRUG

OraVerse

Phentolamine mesylate is a vaso-dilator that was used for treating dermal necrosis and severe hypertension cases since 1952. It is alpha-adrenergic antagonist. Oraverse is supplied in a dose equal to the amount of LA taken in adults and children with weights more than 30 kg. While in children less than 30 kg, it is advised to use only half carpule according the manufacturer's instructions.

Locations (1)

Cairo University

Cairo, El Manial, Egypt