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

Assiut University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: DEX-Nano-Rectal; Drug: DEX-Rectal; Drug: DEX-IV

Study type: Interventional

Funder types: Other

Identifiers

NCT05340725

SECI-IRB-IORG0006563

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

DEX-IV

Active Comparator group

Description:

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.

Treatment:

Drug: DEX-IV

DEX-Rectal

Active Comparator group

Description:

Patients will receive rectal DEX suppository formulation at approximately 1µ/kg an iv. saline placebo. at 30 min. before induction of anesthesia.

Treatment:

Drug: DEX-Rectal

DEX Nano-Rectal

Active Comparator group

Description:

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

Treatment:

Drug: DEX-Nano-Rectal