UnknownPhase 4

The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

120 participantsStarted 2014-12

Plain-language summary

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

Who can participate

Age range

1 Month – 16 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

. written informed consent；
. pediatric patients admitted to intensive care unit after general anesthesia;
. expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -

Exclusion criteria

. congenital heart disease, arrhythmias and heart failure;
. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
. central nervous system disease;
. spinal analgesia or muscle relaxants is used during PICU;
. the drug that affects the nerve conduction is used in one month;
. allergy to the test drug or having other contraindications;
. participated in other studies 30 days prior to admission of PICU; -

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

percentage of time at target sedation score

Timeframe: up to 24 hours

the number of patients requiring the sedation remedy

Timeframe: up to 24 hours

the dosage of midazolam that need for the sedation remedy

Timeframe: up to 24 hours

Trial details

NCT IDNCT02296073

SponsorAnhui Provincial Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Failed Conscious Sedation During Procedure trials

Who can participate

Age range

1 Month – 16 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

. written informed consent；
. pediatric patients admitted to intensive care unit after general anesthesia;
. expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -

Exclusion criteria

. congenital heart disease, arrhythmias and heart failure;
. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
. central nervous system disease;
. spinal analgesia or muscle relaxants is used during PICU;
. the drug that affects the nerve conduction is used in one month;
. allergy to the test drug or having other contraindications;
. participated in other studies 30 days prior to admission of PICU; -