Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.

NCT05340725 | Unknown Phase 2 DMC

• 1 other identifier: SECI-IRB-IORG0006563
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative FLACC pain score

  6 hours.

Study Arms (3)

DEX-IV

ACTIVE COMPARATOR

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

DEX-Rectal

ACTIVE COMPARATOR

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

DEX Nano-Rectal

ACTIVE COMPARATOR

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

Interventions

DEX-IV DRUG

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.

Also known as: Precedex

DEX-IV

DEX-Rectal DRUG

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

Also known as: Precedex

DEX-Rectal

DEX-Nano-Rectal DRUG

Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia

Also known as: Precedex

DEX Nano-Rectal

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I and II.
• Aged 3-7 yrs.
• Undergoing bone marrow aspiration and biopsy.

You may not qualify if:

• Allergy to the study drugs.
• Significant organ dysfunction.
• Cardiac dysrhythmia.
• Congenital heart disease.
• Use of psychotropic medication.
• Mental retardation.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South Egypt cancer institute, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hala Abdel-Ghaffar, MD

  Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdel-Ghaffar, MD

CONTACT

01003812011; hallasaad@yahoo.com

Sahar A Mohamed, MD

CONTACT

01289386665; drsaher2008@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)