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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01326078
• Other study ID #: CRIST011
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: March 28, 2011
• Last updated: March 25, 2014
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2014
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• propofol
3 - 4 mg/kg IV, adjustment dose if necessary

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.	Professor Fernando Figueira Integral Medicine Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time of latency	Time between the injection and loss of the corneal-palpebral reflex	3-10 seconds	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Total dose	The total dose used will be measured in mg/kg/hour.	12 - hours End of procedure	No
Secondary	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	No