Clinical trial NCT05448807: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Soft Tissue Injuries
Keywords: lip biting hematoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Time to return to normal function
timeFrame: 2 hours
Secondary outcomes:
measure: Incidence of self-inflicted soft tissue trauma
timeFrame: 2 hours
measure: Cost effectiveness of oraverse
timeFrame: Through the completion of the study, with average 1 year
measure: post-operative pain by 170 mm Heft-parker visual analogue scale (VAS)
timeFrame: the following 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: main supervisor
name: mahmoud hamdy, professor
role: STUDY_CHAIR
References: