Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.
NCT ID: NCT05340725
Last Updated: 2023-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
45 participants
INTERVENTIONAL
2022-05-01
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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 an iv. saline placebo. at 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 an iv. saline placebo 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 3-7 yrs.
* Undergoing bone marrow aspiration and biopsy.
Exclusion Criteria
* Significant organ dysfunction.
* Cardiac dysrhythmia.
* Congenital heart disease.
* Use of psychotropic medication.
* Mental retardation.
3 Years
7 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hala Saad Abdel-Ghaffar
Principal investigator
Principal Investigators
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Hala Abdel-Ghaffar, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
Locations
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South Egypt cancer institute, Assiut university
Asyut, Assiut Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SECI-IRB-IORG0006563
Identifier Type: -
Identifier Source: org_study_id
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