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

Cristália Produtos Químicos Farmacêuticos Ltda.

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Conditions

Leukemia

Interventions

propofolDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Classification of the sedation level

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

Time frame: time 0

Secondary Outcomes

Time of latency

Time between the injection and loss of the corneal-palpebral reflex

Time frame: 3-10 seconds

Pain at injection

The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.

Time frame: 3 - 10 seconds: during the injection

Physician satisfaction

The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure.

Time frame: 12 hours: end of procedure

Awakening time

Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement).

Time frame: 10 hours: when the patient awakes

Total dose

The total dose used will be measured in mg/kg/hour.

Time frame: 12 - hours End of procedure

Incidence of Adverse Events

Adverse events will be compared in its incidence in the two formulations of propofol during the anesthetic induction and 12 hours after the procedures.

Time frame: 0 to 14 hours

Data from ClinicalTrials.gov

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