Clinical trial NCT05340725: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II.
* Aged 3-7 yrs.
* Undergoing bone marrow aspiration and biopsy.

Exclusion Criteria:

* Allergy to the study drugs.
* Significant organ dysfunction.
* Cardiac dysrhythmia.
* Congenital heart disease.
* Use of psychotropic medication.
* Mental retardation.

Primary outcomes:
measure: Serum concentrations of Dexmedetomidine
timeFrame: 6 hours.
Secondary outcomes:
measure: Postoperative FLACC pain score
timeFrame: 6 hours.
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: South Egypt cancer institute, Assiut university
state: Assiut Governorate
Study officials:
affiliation: Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
name: Hala Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: