WithdrawnPhase 2/3

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

Stopped: The Sponsor has no interest in continuing the study.

0Started 2011-06

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Classification of the sedation level

Timeframe: time 0

Trial details

NCT IDNCT01326078

SponsorCristália Produtos Químicos Farmacêuticos Ltda.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-07

View on ClinicalTrials.gov More Leukemia trials

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.