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

Study Overview
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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.

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.

Official Title
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Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.

Conditions
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Leukemia

Intervention / Treatment
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* Drug: propofol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol nanoemulsion<br>3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given. | Drug: propofol<br>* 3 - 4 mg/kg IV, adjustment dose if necessary<br>|
| Active Comparator: propofol lipid emulsion<br>3-4 mg/kg will be administered by 1 ml per 5 seconds. | Drug: propofol<br>* 3 - 4 mg/kg IV, adjustment dose if necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of latency | Time between the injection and loss of the corneal-palpebral reflex | 3-10 seconds | 
| Pain at injection | The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain. | 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. | 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). | 10 hours: when the patient awakes | 
| Total dose | The total dose used will be measured in mg/kg/hour. | 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. | 0 to 14 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, children, leukemia, bone marrow biopsy