Clinical trial · Interventional
Rectal Dexmedetomidine Niosomes for Postoperative Analgesia in Pediatric Cancer Patients.
The Population Pharmacokinetics and Pharmacodynamics of Rectal Dexmedetomidine Niosomes Administered for Postoperative Analgesia in Pediatric Cancer Patients.
NCT05340725CI-TRIAL-00063395DEX-NANOunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Applying nanotechnology in drug delivery systems improved the bioavailability and kinetic profile of drugs in biological systems
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEX-IV | Drug | — | UNRESOLVED |
| DEX-Nano-Rectal | Drug | — | UNRESOLVED |
| DEX-Rectal | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- DEX-IV
- 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.
- interventionNames
- Drug: DEX-IV
- type
- ACTIVE_COMPARATOR
- label
- DEX-Rectal
- description
- Patients will receive rectal DEX suppository formulation at approximately 1µ/kg an iv. saline placebo. at 30 min. before induction of anesthesia.
- interventionNames
- Drug: DEX-Rectal
- type
- ACTIVE_COMPARATOR
- label
- DEX Nano-Rectal
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 7 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.