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