Actively Recruiting

Phase 3
Age: 5Years - 7Years
All Genders
Healthy Volunteers
NCT05448807

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

Led by Cairo University · Updated on 2025-07-10

100

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years - 7Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5-7 years
  • Patients needing dental procedures requiring local anesthesia
  • Healthy children without systemic or mental disorders
  • Normal lip sensation before local anesthesia
  • Normal pediatric functional assessment battery for smiling, speaking, and drinking with no drooling
Not Eligible

You will not qualify if you...

  • Children needing dental treatment without local anesthesia
  • Children who did not achieve full numbness and require more anesthesia
  • Children unable to distinguish numb side from non-numb side
  • Children unwilling to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, El Manial, Egypt, 11562

Actively Recruiting

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Research Team

A

alaa saad abourawash

CONTACT

P

passant nagy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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