Postoperative PainPhase 2/3DEX-NANONCT05340725
Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.
A Phase 2/3 study testing DEX-IV, DEX-Rectal and DEX-Nano-Rectal in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- DEX-IV, DEX-Rectal and DEX-Nano-Rectal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I and II.
- Aged 3-7 yrs.
- Undergoing bone marrow aspiration and biopsy.
Who cannot join
- Allergy to the study drugs.
- Significant organ dysfunction.
- Cardiac dysrhythmia.
- Congenital heart disease.
- Use of psychotropic medication.
- Mental retardation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt cancer institute, Assiut university
Asyut, Assiut Governorate, 715715
Hala S Abdel-Ghaffar, MD, +2 01003812011, hallasaad@yahoo.com
Saher A Mohamed, MD, +2 01003611410, drsaher2008@yahoo.com
About this study
Official title: The Population Pharmacokinetics and Pharmacodynamics of Rectal Dexmedetomidine Niosomes Administered for Postoperative Analgesia in Pediatric Cancer Patients.
Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- DEX-IV, DEX-Rectal, DEX-Nano-Rectal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEX-IVDrug
Also called Precedex
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-RectalDrug
Also called Precedex
Patients will receive rectal DEX suppository formulation at approximately 1µ/kg at 30 min. before induction of anesthesia
DEX-Nano-RectalDrug
Also called Precedex
Patients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: DEX-Nano-Rectal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours.
Secondary outcomes (1)
Postoperative FLACC pain score
Pain intensity will be assessed using the FLACC scale, with a maximum score of 10.
Measured: 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala Abdel-Ghaffar, MD, Principal investigator, Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340725
- Sponsor's protocol ID
- SECI-IRB-IORG0006563
- Acronym
- DEX-NANO
- Status last verified
- Jan 2023
- First submitted
- 10 Apr 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Population Pharmacokinetics and Pharmacodynamics of Rectal Dexmedetomidine Niosomes Administered for Postoperative Analgesia in Pediatric Cancer Patients.
- ClinicalTrials.gov ID
- NCT05340725
- Acronym / sponsor ID
- DEX-NANO / SECI-IRB-IORG0006563
- Conditions
- Postoperative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| DEX-IV | Active comparator | Drug: DEX-IVPatients 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-Rectal | Active comparator | Drug: DEX-RectalPatients will receive rectal DEX suppository formulation at approximately 1µ/kg an iv. saline placebo. at 30 min. before induction of anesthesia. |
| DEX Nano-Rectal | Active comparator | Drug: DEX-Nano-RectalPatients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg an iv. saline placebo at 30 min. before induction of anesthesia |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I and II.
- Aged 3-7 yrs.
- Undergoing bone marrow aspiration and biopsy.
Key exclusion criteria (6 listed)
- Allergy to the study drugs.
- Significant organ dysfunction.
- Cardiac dysrhythmia.
- Congenital heart disease.
- Use of psychotropic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEX-IVAlso: Precedexpatients 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. | Drug | DEX-IV |
| DEX-RectalAlso: PrecedexPatients will receive rectal DEX suppository formulation at approximately 1µ/kg at 30 min. before induction of anesthesia | Drug | DEX-Rectal |
| DEX-Nano-RectalAlso: PrecedexPatients will receive rectal DEX suppository in the Niosomes formulation at approximately 1µ/kg at 30 min. before induction of anesthesia | Drug | DEX Nano-Rectal |
Primary outcome
Serum concentrations of Dexmedetomidine
Time frame: 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
1 secondary outcome
Postoperative FLACC pain score
Time frame: 6 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Abdel-Ghaffar, MD principal investigator
Professor of anesthesia and intensive care, faculty of medicine, Assiut university, Assiut, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DEX-IV, DEX-Rectal and DEX-Nano-Rectal in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala S Abdel-Ghaffar, MD (01003812011 ext. +20, hallasaad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of Dexmedetomidine (time frame: 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.