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

Primary Purpose

Soft Tissue Injuries

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OraVerse
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Soft Tissue Injuries focused on measuring lip biting hematoma

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    participants receiving oraverse injection after local anaesthetic administration

    participants with no drug after local anaesthetic administration

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Incidence of self-inflicted soft tissue trauma
    we observe clinical signs of redness, swelling, hematoma or ulcers due to lip biting at dismal of each participant
    Cost effectiveness of oraverse
    we measure the cost effectiveness of the intervention drug through Incremental cost-effectiveness ratio (ICER) ICER=(C1-C0)/ (E1-E0) C1= cost of intervention drug C0= cost of control E1= effect of intervention drug E0= effect of control
    post-operative pain by 170 mm Heft-parker visual analogue scale (VAS)
    it is 170mm scale from 0 to 170 mm and it represents no pain: corresponds to 0 mm. mild pain: greater than 0 mm and less than or equal to 54 mm and included the description of faint and weak pain. moderate pain: greater than 54 mm and less than 114 mm. severe pain: equal to or greater than 114 mm to 170 mm and includes the description of strong and intense pain

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    September 29, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05448807
    Brief Title
    Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Injuries
    Keywords
    lip biting hematoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    participants receiving oraverse injection after local anaesthetic administration
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    participants with no drug after local anaesthetic administration
    Arm Type
    No Intervention
    Arm Description
    participants don't receive any reversal agent or placebo after the completion of their dental procedures.
    Intervention Type
    Drug
    Intervention Name(s)
    OraVerse
    Other Intervention Name(s)
    phentolamine mesylate
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Time to return to normal function
    Description
    it is the time needed for the soft intraoral tisues e.g lips, tongue to return to their normal functions after local anaesthesia
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Incidence of self-inflicted soft tissue trauma
    Description
    we observe clinical signs of redness, swelling, hematoma or ulcers due to lip biting at dismal of each participant
    Time Frame
    2 hours
    Title
    Cost effectiveness of oraverse
    Description
    we measure the cost effectiveness of the intervention drug through Incremental cost-effectiveness ratio (ICER) ICER=(C1-C0)/ (E1-E0) C1= cost of intervention drug C0= cost of control E1= effect of intervention drug E0= effect of control
    Time Frame
    Through the completion of the study, with average 1 year
    Title
    post-operative pain by 170 mm Heft-parker visual analogue scale (VAS)
    Description
    it is 170mm scale from 0 to 170 mm and it represents no pain: corresponds to 0 mm. mild pain: greater than 0 mm and less than or equal to 54 mm and included the description of faint and weak pain. moderate pain: greater than 54 mm and less than 114 mm. severe pain: equal to or greater than 114 mm to 170 mm and includes the description of strong and intense pain
    Time Frame
    the following 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    alaa saad abourawash
    Phone
    01144942076
    Email
    alaa.saad@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    passant nagy
    Phone
    01280557107
    Email
    passant.nagi@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    mahmoud hamdy, professor
    Organizational Affiliation
    main supervisor
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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