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

Cristalia

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Leukemia

Treatments: Drug: propofol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01326078

CRIST011

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

propofol nanoemulsion

Experimental group

Description:

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

Treatment:

Drug: propofol

propofol lipid emulsion

Active Comparator group

Description:

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

Treatment:

Drug: propofol