Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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

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Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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propofol nanoemulsion

3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

3 - 4 mg/kg IV, adjustment dose if necessary

propofol lipid emulsion

3-4 mg/kg will be administered by 1 ml per 5 seconds.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

3 - 4 mg/kg IV, adjustment dose if necessary

Interventions

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propofol

3 - 4 mg/kg IV, adjustment dose if necessary

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No