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

NCT ID: NCT05448807

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-05
• Study Completion Date: 2026-06-30

Brief 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

Detailed Description

Local anesthesia is the most common method for pain control during any dental procedures, but it is also one of the factors that can trigger discomfort and anxiety in children. Local anesthetics are primarily used to reversibly block action potentials that create impulse conduction along neural axons carrying sensory or motor signals. This occurs by blocking voltage-gated sodium channels. A prospective study of 320 children by College et al., (2000), reported soft tissue trauma frequency as 18%, 16%, 13% and 7% in children who are; less than 4, 4-7, 8-11 and more than 12 years old, respectively following inferior alveolar nerve block anesthesia and its numbing effect.

The search for a pharmacologic means of minimizing postoperative soft tissue anesthesia has focused on phentolamine mesylate (PM), where an injectable form has been developed. Following the administration of local anesthetic with vasoconstrictor, a subsequent phentolamine injection into the same location enhances the redistribution of the local anesthetic away from the injection site as it is an alpha-adrenergic blocking agent, explaining the more rapid return of normal intraoral and perioral sensation.

An intra-oral preparation of PM for the reversal of soft tissue anesthesia was approved by the FDA in May 2008, to be used for patients > 6 years of age and weighing > 15 kg. Later, in March 2016, the FDA approved its use in pediatric patients 3 years and older. Dosage form of OraVerse (phentolamine mesylate) is 0.4 mg/1.7 ml solution per cartridge. Its maximum dose is 2 cartridges in adults. The first published placebo-controlled phase two study reported that, in 10- to 58-year-old dental patients, an injection of phentolamine, at a one-to-one ratio at the site of the previous injection of local anesthesia, accelerated median recovery time to normal sensation of the upper and lower lips by 85 minutes.

Conditions

Soft Tissue Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

participants receiving oraverse injection after local anaesthetic administration

participants receive phentolamine mesylate (Oraverse) injection after the completion of their dental procedures with ratio 1:1 to LA in children weighed 30 kg and more while in children less than 30 kg only half of the amount of the cartridge is administrated.

Group Type: EXPERIMENTAL

OraVerse

Intervention Type: DRUG

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.

participants with no drug after local anaesthetic administration

participants don't receive any reversal agent or placebo after the completion of their dental procedures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OraVerse

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.

Intervention Type: DRUG

Other Intervention Names

phentolamine mesylate

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, 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Saad Abourawash Tolba

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mahmoud hamdy, professor

Role: STUDY_CHAIR

main supervisor

Locations

Cairo University

Cairo, El Manial, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

alaa saad abourawash

Role: CONTACT

alaa.saad@dentistry.cu.edu.eg

01144942076

passant nagy

Role: CONTACT

passant.nagi@dentistry.cu.edu.eg

01280557107

Facility Contacts

Alaa Saad, bachelor degree of science

Role: primary

alaa.saad@dentistry.cu.edu.eg

00201144942076

Passant Nagi

Role: backup

passant.nagi@dentistry.cu.edu.eg

00201280557107

Other Identifiers

71192

Identifier Type: -

Identifier Source: org_study_id