Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children
ConditionSoft Tissue Injuries
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-7
SponsorCairo University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
OraVerse
DrugPhentolamine 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: participants receiving oraverse injection after local anaesthetic administrationExperimental treatment 1 intervention
Group B: participants with no drug after local anaesthetic administrationNo intervention 0 interventions
Trial outcomes
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
Time frame
2 hoursSecondary outcomes
1
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
Time frame
2 hours2
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
Time frame
Through the completion of the study, with average 1 year3
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
Time frame
the following 24 hoursSponsors and contacts
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Source ClinicalTrials.gov