Back to results

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

Primary Purpose

Leukemia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

propofol

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring sedation, children, leukemia, bone marrow biopsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

propofol nanoemulsion

propofol lipid emulsion

Arm Description

3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.

3-4 mg/kg will be administered by 1 ml per 5 seconds.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time of latency

Time between the injection and loss of the corneal-palpebral reflex

Pain at injection

The pain will be measured by CHEOPS Scale which evaluates the behavior of the child against pain.

Physician satisfaction

The satisfaction of the medical specialist will be assessed through a questionnaire that assesses conditions of sedation for the procedure.

Awakening time

Time between the last dose of propofol and the time when the patient awakes (cry, eyes opening and spontaneous movement).

Total dose

The total dose used will be measured in mg/kg/hour.

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.

Full Information

NCT ID

NCT01326078

First Posted

March 28, 2011

Last Updated

March 25, 2014

Sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Collaborators

Professor Fernando Figueira Integral Medicine Institute

1. Study Identification

Unique Protocol Identification Number

NCT01326078

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Withdrawn

Why Stopped

The Sponsor has no interest in continuing the study.

Study Start Date

June 2011 (undefined)

Primary Completion Date

July 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cristália Produtos Químicos Farmacêuticos Ltda.

Collaborators

Professor Fernando Figueira Integral Medicine Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia

Keywords

sedation, children, leukemia, bone marrow biopsy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

propofol nanoemulsion

Arm Type

Experimental

Arm Description

3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.

Arm Title

propofol lipid emulsion

Arm Type

Active Comparator

Arm Description

3-4 mg/kg will be administered by 1 ml per 5 seconds.

Intervention Type

Drug

Intervention Name(s)

propofol

Intervention Description

3 - 4 mg/kg IV, adjustment dose if necessary

Primary Outcome Measure Information:

Title

Classification of the sedation level

Description

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

Secondary Outcome Measure Information:

Title

Time of latency

Description

Time between the injection and loss of the corneal-palpebral reflex

Time Frame

3-10 seconds

Title

Pain at injection

Description

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

Title

Physician satisfaction

Description

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

Title

Awakening time

Description

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

Title

Total dose

Description

The total dose used will be measured in mg/kg/hour.

Time Frame

12 - hours End of procedure

Title

Incidence of Adverse Events

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luciana C Lima, PhD

Organizational Affiliation

IMIP

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs