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

Phase 2

Withdrawn

• Conditions: Leukemia
• Interventions: Drug: propofol

• Registration Number: NCT01326078
• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Brief 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.

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Study Start: 2011-06
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Classification of the sedation level	time 0	Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale.

Secondary Outcome Measures

Name	Time	Method
Total dose	12 - hours End of procedure	The total dose used will be measured in mg/kg/hour.
Time of latency	3-10 seconds	Time between the injection and loss of the corneal-palpebral reflex
Pain at injection	3 - 10 seconds: during the injection	The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.
Physician satisfaction	12 hours: end of procedure	The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure.
Awakening time	10 hours: when the patient awakes	Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement).
Incidence of Adverse Events	0 to 14 hours	Adverse events will be compared in its incidence in the two formulations of propofol during the anesthetic induction and 12 hours after the procedures.