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Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children

RecruitingPhase 3Ages 5 Years - 7 YearsAllCairo University
NCT05448807 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: Children aged 5-7 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.
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What it tests

  • OraVerse
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Where

1 site
Cairo University
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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