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
Qualifiers
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
Treatments tested in this trial
- OraVerse
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov