Study Stopped
The Sponsor has no interest in continuing the study.
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.
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2011
Shorter than P25 for phase_2 leukemia
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 26, 2014
March 1, 2014
1 month
March 28, 2011
March 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Time of latency
3-10 seconds
Pain at injection
3 - 10 seconds: during the injection
Physician satisfaction
12 hours: end of procedure
Awakening time
10 hours: when the patient awakes
Total dose
12 - hours End of procedure
- +1 more secondary outcomes
Study Arms (2)
propofol nanoemulsion
EXPERIMENTAL3-4 mg/kg of propofol nanoemulsion will be administered by 1mL per 5 seconds, adjustment dose can be given.
propofol lipid emulsion
ACTIVE COMPARATOR3-4 mg/kg will be administered by 1 ml per 5 seconds.
Interventions
3 - 4 mg/kg IV, adjustment dose if necessary
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luciana C Lima, PhD
IMIP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 30, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2011
Study Completion
December 1, 2011
Last Updated
March 26, 2014
Record last verified: 2014-03