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Brief Title: Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.
Official Title: The Population Pharmacokinetics and Pharmacodynamics of Rectal Dexmedetomidine Niosomes Administered for Postoperative Analgesia in Pediatric Cancer Patients.
Study ID: NCT05340725
Brief Summary: Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems
Detailed Description: Nanotechnology which is focused on studying the properties and the applications of materials with structure size in the range of 1-100 nm has been widely used in various fields. In biomedical research fields, nanotechnology has been used to design and development of drug delivery systems (DDSs). Nanotechnology-based drug delivery systems (NDDSs) offer many potential advantages in cancer treatment, such as improving targeting of the therapeutic drugs, protecting drugs from degradation during in vivo transport, controlled drug release at specific sites or cells in response to specific signals, and thus improving the therapeutic efficacy while minimizing side effects. Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems. Advances in nanotechnology aid in targeting drugs to specific molecular targets and safely delivering drugs to specific sites of action. The sustained release of nano-drug delivery systems enhances the controlled release profile of loaded drugs, thereby minimizing the dosage-regimen. The aim of this study will be to investigate the population pharmacokinetics and pharmacodynamics of rectal dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients undergoing bone marrow biopsy and aspiration in comparison with the intravenous and rectal plain formulation.
Minimum Age: 3 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
South Egypt cancer institute, Assiut university, Asyut, Assiut Governorate, Egypt
Name: Hala Abdel-Ghaffar, MD
Affiliation: Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
Role: PRINCIPAL_INVESTIGATOR