Leukemia
Conditions
Keywords
sedation, children, leukemia, bone marrow biopsy
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.
Interventions
DRUGpropofol
3 - 4 mg/kg IV, adjustment dose if necessary
Sponsors
Professor Fernando Figueira Integral Medicine Institute
Cristália Produtos Químicos Farmacêuticos Ltda.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time of latency | 3-10 seconds | Time between the injection and loss of the corneal-palpebral reflex |
| Total dose | 12 - hours End of procedure | The total dose used will be measured in mg/kg/hour. |
| 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. |
| 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). |
Outcome results
None listed