Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
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
Cairo University
100 participants
Jul 5, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria4
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05448807