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

This study has been withdrawn prior to enrollment.
(The Sponsor has no interest in continuing the study.)
Sponsor:
Collaborator:
Professor Fernando Figueira Integral Medicine Institute
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01326078
First received: March 28, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: propofol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:
  • Classification of the sedation level [ Time Frame: time 0 ] [ Designated as safety issue: Yes ]
    Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale.


Secondary Outcome Measures:
  • Time of latency [ Time Frame: 3-10 seconds ] [ Designated as safety issue: No ]
    Time between the injection and loss of the corneal-palpebral reflex

  • Pain at injection [ Time Frame: 3 - 10 seconds: during the injection ] [ Designated as safety issue: No ]
    The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.

  • Physician satisfaction [ Time Frame: 12 hours: end of procedure ] [ Designated as safety issue: No ]
    The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure.

  • Awakening time [ Time Frame: 10 hours: when the patient awakes ] [ Designated as safety issue: No ]
    Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement).

  • Total dose [ Time Frame: 12 - hours End of procedure ] [ Designated as safety issue: No ]
    The total dose used will be measured in mg/kg/hour.

  • Incidence of Adverse Events [ Time Frame: 0 to 14 hours ] [ Designated as safety issue: No ]
    Adverse events will be compared in its incidence in the two formulations of propofol during the anesthetic induction and 12 hours after the procedures.


Enrollment: 0
Study Start Date: June 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: propofol nanoemulsion
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 IV, adjustment dose if necessary
Active Comparator: propofol lipid emulsion
3-4 mg/kg will be administered by 1 ml per 5 seconds.
Drug: propofol
3 - 4 mg/kg IV, adjustment dose if necessary

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326078

Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Professor Fernando Figueira Integral Medicine Institute
Investigators
Principal Investigator: Luciana C Lima, PhD IMIP
  More Information

No publications provided

Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT01326078     History of Changes
Other Study ID Numbers: CRIST011
Study First Received: March 28, 2011
Last Updated: March 25, 2014
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
sedation
children
leukemia
bone marrow biopsy

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 01, 2014