Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
Recruiting
Phase 3
Interventional Study
Soft Tissue Injuries
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 5 – 7
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 100 (estimated)
- Sponsor
- Cairo University · Other
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About This Trial
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 (Oravers…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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, s…
Contacts