Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients. (DEX-NANO)

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: DEX-IV; Drug: DEX-Rectal; Drug: DEX-Nano-Rectal

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hala S Abdel-Ghaffar, MD; Phone Number: +20 01003812011; Email: hallasaad@yahoo.com
• Study Contact Backup: Name: Sahar A Mohamed, MD; Phone Number: 01289386665; Email: drsaher2008@yahoo.com

Study Locations

• Egypt
  • Assiut Governorate
    • Asyut, Assiut Governorate, Egypt, 715715
      • Recruiting
      • South Egypt Cancer Institute, Assiut University
      • Contact: Hala S Abdel-Ghaffar, MD; Phone Number: +2 01003812011; Email: hallasaad@yahoo.com
      • Contact: Saher A Mohamed, MD; Phone Number: +2 01003611410; Email: drsaher2008@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DEX-IV; Patients will receive iv DEX 1µ/kg diluted in 100 ml saline and given slowly iv infusion over 10 min. and rectal placebo 30 min. before induction of anesthesia.	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.; Other Names: Precedex
Active Comparator: DEX-Rectal; Patients will receive rectal DEX suppository formulation at approximately 1µ/kg an iv. saline placebo. at 30 min. before induction of anesthesia.	Drug: DEX-Rectal; Patients will receive rectal DEX suppository formulation at approximately 1µ/kg at 30 min. before induction of anesthesia; Other Names: Precedex
Active Comparator: DEX Nano-Rectal; Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg an iv. saline placebo at 30 min. before induction of anesthesia	Drug: DEX-Nano-Rectal; Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative FLACC pain score	Pain intensity will be assessed using the FLACC scale, with a maximum score of 10.	6 hours.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala Abdel-Ghaffar, MD, Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: SECI-IRB-IORG0006563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No