Ignite Creation Date:
2024-05-06 @ 5:49 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05448807
Status:
UNKNOWN
Last Update Posted:
2022-10-03
First Post:
2022-06-29
Brief Title:
Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 04 mg17 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
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 04 mg17 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None