Actively Recruiting
Effectiveness of Phentolamine Mesylate as a Reversal Agent for Local Anesthesia to Reduce Soft Tissue Injuries in Children Undergoing Dental Procedures
Led by Cairo University · Updated on 2025-07-10
100
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Local anesthesia is commonly used to control pain during dental procedures but often causes discomfort and anxiety in children due to the lingering numbness that can last from 3 to 5 hours. This numbness may lead to soft tissue injuries, especially in younger children. Researchers are studying phentolamine mesylate (Oraverse), a drug approved by the FDA to reverse the numbing effect of local anesthesia more quickly by blocking alpha-adrenergic receptors and helping restore normal mouth sensation faster. In this study, children aged 5 to 7 undergoing dental procedures with local anesthesia will be randomly assigned to receive either an injection of phentolamine mesylate after their dental procedure or no reversal agent (placebo). Dosage depends on the child's weight: those over 30 kg receive a full cartridge matching the local anesthesia dose, while those under 30 kg receive half a cartridge. The study is double-blinded, so neither participants nor researchers know who receives the drug or placebo. Participants will be monitored for up to 2 hours after treatment to measure the time it takes for normal mouth function to return and to check for any self-inflicted soft tissue injuries. Additional assessments include postoperative pain within 24 hours and cost-effectiveness over about one year. Children will be evaluated for normal lip sensation and oral functions before the procedure, ensuring safe participation in this randomized clinical trial led by Cairo University.
CONDITIONS
Brief Title
Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 7 years
- Need for dental procedures requiring local anesthesia
- Healthy children without systemic or mental disorders
- Normal lip sensation before local anesthesia
- Normal ability to smile, speak, and drink without drooling as assessed by pediatric functional assessment
You will not qualify if you...
- Dental treatments that do not require local anesthesia
- Children who do not achieve full numbness and require additional anesthesia
- Children unable to distinguish the numb side from the normal side
- Children unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo dental procedures with local anesthesia, followed by either an injection of phentolamine mesylate (Oraverse) to reverse the anesthesia or no reversal agent.
1 visit (in-person) on the day of the dental procedure
Duration - Up to 1 year
Participants are monitored for return to normal function, incidence of soft tissue trauma, post-operative pain, and cost effectiveness of the treatment.
1 to 2 follow-up visits within 24 hours and additional remote follow-up for up to 1 year
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, El Manial, Egypt, 11562
Actively Recruiting
Research Team
A
alaa saad abourawash
P
passant nagy
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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