Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.

Study Overview
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Brief Summary
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Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: DEX-IV
* Drug: DEX-Rectal
* Drug: DEX-Nano-Rectal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DEX-IV<br>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<br>* 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.<br>* Other names: Precedex;|
| Active Comparator: DEX-Rectal<br>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<br>* Patients will receive rectal DEX suppository formulation at approximately 1µ/kg at 30 min. before induction of anesthesia<br>* Other names: Precedex;|
| Active Comparator: DEX Nano-Rectal<br>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<br>* Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia<br>* Other names: Precedex;|

What is the study measuring?
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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. |