Postoperative Pain
Conditions
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.
Interventions
DRUGDEX-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.
DRUGDEX-Rectal
Patients will receive rectal DEX suppository formulation at approximately 1µ/kg at 30 min. before induction of anesthesia
DRUGDEX-Nano-Rectal
Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An independent investigator not involved in the study will open the envelopes 1 h before induction of anesthesia and will prepare the study drug solutions in identical syringes and formulations with matching random codes.
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentrations of Dexmedetomidine | 6 hours. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative FLACC pain score | 6 hours. | Pain intensity will be assessed using the FLACC scale, with a maximum score of 10. |
Countries
Egypt
Contacts
Primary ContactHala S Abdel-Ghaffar, MD
Backup ContactSahar A Mohamed, MD
Outcome results
None listed