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

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: Phentolamine

Criteria

Inclusion Criteria:

Children aged 6-8 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 Criteria:

• 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.