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

NCT05448807 | Recruiting Phase 3 DMC

• 1 other identifier: 71192
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Soft Tissue Injuries

Keywords

lip biting hematoma

Outcome Measures

Primary Outcomes (1)

• Time to return to normal function

  it is the time needed for the soft intraoral tisues e.g lips, tongue to return to their normal functions after local anaesthesia

  2 hours

Secondary Outcomes (3)

• Incidence of self-inflicted soft tissue trauma

  2 hours

• Cost effectiveness of oraverse

  Through the completion of the study, with average 1 year

• post-operative pain by 170 mm Heft-parker visual analogue scale (VAS)

  the following 24 hours

Study Arms (2)

participants receiving oraverse injection after local anaesthetic administration

EXPERIMENTAL

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.

Drug: OraVerse

participants with no drug after local anaesthetic administration

NO INTERVENTION

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

Interventions

OraVerse 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.

Also known as: phentolamine mesylate

participants receiving oraverse injection after local anaesthetic administration

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, El Manial, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Soft Tissue Injuries

Interventions

Phentolamine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• mahmoud hamdy, professor

  main supervisor

  STUDY CHAIR

Central Study Contacts

alaa saad abourawash

CONTACT

01144942076; alaa.saad@dentistry.cu.edu.eg

passant nagy

CONTACT

01280557107; passant.nagi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This research will be a double blinded study, where the patient (participant) and the statistician will be blind to the treatment groups (to avoid detection and reporting bias). Information bias, selection bias, and confounding will be avoided in this study. The operator will not be blinded to the treatment as the test group will receive a PM (Oraverse) injection while the control group will not receive a reversal agent.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Intervention group: they 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. Control group: they don't receive any reversal agent or placebo after the completion of their dental procedures.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 7, 2022
• Study Start: July 5, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)