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Search / Trial NCT05448807

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

Launched by CAIRO UNIVERSITY · Jul 6, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Lip Biting Hematoma

ClinConnect Summary

This clinical trial is studying how well a medicine called phentolamine mesylate (brand name Oraverse) works to quickly reverse the numb feeling caused by local anesthesia in children after dental treatments. Local anesthesia is the medicine that makes your mouth numb during dental work, but it can last for several hours, which can be uncomfortable for kids. This study aims to see if phentolamine mesylate can help children regain normal feeling and movement in their mouth faster after their dental procedure is done.

Children between the ages of 5 and 7 who need dental work with local anesthesia and are generally healthy may be eligible to join. Before the treatment, kids should have normal lip feeling and be able to smile, speak, and drink without drooling. If a child doesn’t need local anesthesia or doesn’t become fully numb during the dental procedure, they won’t be able to participate. For families who join, the child will receive dental care as usual, and if eligible, they may be given the medicine to help reverse the numbness more quickly. This trial is currently looking for participants.

Gender

ALL

Eligibility criteria

  • 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.

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, El Manial, Egypt

Patients applied

0 patients applied

Trial Officials

mahmoud hamdy, professor

Study Chair

main supervisor

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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