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Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
Sponsor: Cairo University
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
Conditions
Interventions
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