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

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborator: Professor Fernando Figueira Integral Medicine Institute
• Treatments: Propofol

Criteria

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