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Comparison of Nanoemulsion of Propofol and Lipid Emulsion of Propofol in a Non-invasive Ambulatory Procedures Children


Phase 2/Phase 3
6 Years
12 Years
Not Enrolling
Both
Leukemia, Bone Marrow Biopsy

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Trial Information

Comparison of Nanoemulsion of Propofol and Lipid Emulsion of Propofol in a Non-invasive Ambulatory Procedures Children


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.


Inclusion Criteria:



- Lumbar Puncture or bone marrow biopsy

- Peripheral Intravenous access available on dorsal regional hand

- Parents or responsible for the child consent participation.

Exclusion Criteria:

- Relative or absolute contraindications use of propofol and excipients

- Contraindications of general anesthesia or sedation with propofol

- Allergy to 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, or doesn´t have condition

- State of compromised vital functions such as ventilation and hemodynamic balance

- Liver cancer

- Changes in the safety exams

- Others comorbidity in the investigator opinion

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Classification of the sedation level

Outcome Description:

Instantly after the loss of consciousness (loss of corneal-palpebral reflex)will be measure the sedation using the Ramsay Modified Scale

Outcome Time Frame:

time 0

Safety Issue:

Yes

Principal Investigator

Luciana C Lima, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

IMIP

Authority:

Brazil: Ethics Committee

Study ID:

CRIST011

NCT ID:

NCT01326078

Start Date:

June 2011

Completion Date:

December 2011

Related Keywords:

  • Leukemia
  • Bone Marrow Biopsy
  • sedation
  • children
  • leukemia
  • bone marrow biopsy
  • Leukemia

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