Trials / Withdrawn
WithdrawnNCT01326078
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.
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | propofol | 3 - 4 mg/kg IV, adjustment dose if necessary |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2011-07-01
- Completion
- 2011-12-01
- First posted
- 2011-03-30
- Last updated
- 2014-03-26
Source: ClinicalTrials.gov record NCT01326078. Inclusion in this directory is not an endorsement.