A Phase 2/3 interventional study of propofol in Leukemia, sponsored by Cristália Produtos Químicos Farmacêuticos Ltda.. Withdrawn. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-03-26.
Sponsored by Cristália Produtos Químicos Farmacêuticos Ltda. · Phase 2/3, Interventional, and Supportive care
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
Browse Leukemia studies →Cristália Produtos Químicos Farmacêuticos Ltda. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.
Drug: propofol
3-4 mg/kg will be administered by 1 ml per 5 seconds.
Drug: propofol
3 - 4 mg/kg IV, adjustment dose if necessary
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
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
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Cristália Produtos Químicos Farmacêuticos Ltda.