Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Soft Tissue Injuries
In brief
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
Key facts
- Study ID
- NCT05448807
- Run by
- Cairo University
- People needed
- 100
- Starts
- 2025-07-05
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-07-10
Who can join
Age: 5 and older, up to 7. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Children aged 5-7 years.
- Patients in need of dental procedures requiring local anaesthesia.
- Healthy Children without any systemic or mental disorders.
- Normal lip sensation before administration of LA.
- Normal paediatric functional assessment battery (pFAB) for smiling, speaking and drinking and absence of drooling.
You may not qualify if…
- Children seeking dental treatment that does not necessitate local anaesthesia.
- Children who didn't achieve profound numbness requiring additional anaesthesia.
- Children who lack the ability to distinct the anaesthetised numb side from the non-anaesthetised one.
- Children who are not willing to participate in the study.
Where it is running
- Cairo University — Cairo, El Manial, Egypt (enrolling)
Full record on ClinicalTrials.gov
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