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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This study has been withdrawn prior to enrollment.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

March 28, 2011
March 25, 2014
June 2011
July 2011   (final data collection date for primary outcome measure)
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.
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 measure the sedation using the Ramsay Modified Scale
Complete list of historical versions of study NCT01326078 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 measure using the CHEOPS scale during the injection of propofol.
  • hematologist satisfaction [ Time Frame: 12 hours: end of procedure ] [ Designated as safety issue: No ]
    The hematolgist will evaluate the sedation of propofol by responding the questionnaire.
  • 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 (crys, opens eyes, and moves.
  • Total dose [ Time Frame: 12 - hours End of procedure ] [ Designated as safety issue: No ]
    The total dose use will be measure in mg/kg/hour
  • Incidence of Adverse Events [ Time Frame: 0 to 14 hours ] [ Designated as safety issue: No ]
    The incidence of adverse events will be measure during the anesthethic induction and 12 hours after the procedures.
Not Provided
Not Provided
 
Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.
Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Leukemia
Drug: propofol
3 - 4 mg/kg IV, adjustment dose if necessary
  • Experimental: propofol nanoemulsion
    3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.
    Intervention: Drug: propofol
  • Active Comparator: propofol lipid emulsion
    3-4 mg/kg will be administered by 1 ml per 5 seconds.
    Intervention: Drug: propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01326078
CRIST011
No
Cristália Produtos Químicos Farmacêuticos Ltda.
Cristália Produtos Químicos Farmacêuticos Ltda.
Professor Fernando Figueira Integral Medicine Institute
Principal Investigator: Luciana C Lima, PhD IMIP
Cristália Produtos Químicos Farmacêuticos Ltda.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP