Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.

Postoperative Pain Clinical Trial

— DEX-NANO  

Official title:

The Population Pharmacokinetics and Pharmacodynamics of Rectal Dexmedetomidine Niosomes Administered for Postoperative Analgesia in Pediatric Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340725
• Other study ID #: SECI-IRB-IORG0006563
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Hala S Abdel-Ghaffar, MD
• Phone: 01003812011
• Email: hallasaad[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• DEX-IV
patients will receive iv DEX 1µ/kg diluted in 100 ml saline and given slowly iv infusion over 10 min. 30 min. before induction of anesthesia.
• DEX-Rectal
Patients will receive rectal DEX suppository formulation at approximately 1µ/kg at 30 min. before induction of anesthesia
• DEX-Nano-Rectal
Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia

Locations

Country	Name	City	State
Egypt	South Egypt cancer institute, Assiut university	Asyut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentrations of Dexmedetomidine	Pharmacokinetic parameters will be determined using noncompartmental method with WinNonlin professional Version 2.1 software (Pharsight Corporation, Mountain View, CA) based on measurement of plasma concentrations of DEX	6 hours.
Secondary	Postoperative FLACC pain score	Pain intensity will be assessed using the FLACC scale, with a maximum score of 10.	6 hours.