Clinical trial · Interventional
Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.
Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.
NCT01326078CI-TRIAL-00014093withdrawnPhase 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
Why stopped (as posted): The Sponsor has no interest in continuing the study.
Summary
Brief summary (as posted)
The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| propofol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- propofol nanoemulsion
- description
- 3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.
- interventionNames
- Drug: propofol
- type
- ACTIVE_COMPARATOR
- label
- propofol lipid emulsion
- description
- 3-4 mg/kg will be administered by 1 ml per 5 seconds.
- interventionNames
- Drug: propofol
Primary outcomes (1)
- measure
- Classification of the sedation level
- timeFrame
- time 0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Lumbar Puncture or Myelogram * Peripheral Intravenous access available in the veins on the dorsal region of the hand * The informed consent signed by the legal responsible of the child allowing the participation in the study Exclusion Criteria: * Relative or absolute contraindications use of propofol and excipients * Contraindications to the patient undergo general anesthesia or sedation with drug * Allergy derived from egg or soy * Use of pre-medication * Patient receiving psychotropic drugs * Use of opioid within 24 hours * The responsible for the children unable to decide for his participation * The severity of the condition wich compromises vital functions such as ventilation and hemodynamic balance * Liver cancer which compromises its function * Changes in the blood tests * Others comorbidities in the investigator opinion
References
Publications (0)
Data not yet available
No reference posted for this study.