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

March 25, 2014 updated by: Cristália Produtos Químicos Farmacêuticos Ltda.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Classification of the sedation level
Time Frame: time 0
Instantly after the loss of consciousness (loss of corneal-palpebral reflex) will be measured the sedation using the Ramsay Modified Scale.
time 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of latency
Time Frame: 3-10 seconds
Time between the injection and loss of the corneal-palpebral reflex
3-10 seconds
Pain at injection
Time Frame: 3 - 10 seconds: during the injection
The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.
3 - 10 seconds: during the injection
Physician satisfaction
Time Frame: 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.
12 hours: end of procedure
Awakening time
Time Frame: 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).
10 hours: when the patient awakes
Total dose
Time Frame: 12 - hours End of procedure
The total dose used will be measured in mg/kg/hour.
12 - hours End of procedure
Incidence of Adverse Events
Time Frame: 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.
0 to 14 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Collaborators

Professor Fernando Figueira Integral Medicine Institute

Investigators

  • Principal Investigator: Luciana C Lima, PhD, IMIP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRIST011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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