TerminatedPhase 2

Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)

Stopped: futility reasons

Italy45 participantsStarted 2018-08-30

Plain-language summary

This interventional study evaluates the efficacy of dexmedetomidine during weaning from analgesic and sedative drugs in reducing the occurrence of the withdrawal syndrome in PICU. All enrolled patients will undergo the same weaning regimen one half will receive dexmedetomidine while the other will receive a placebo.

Who can participate

Age range

7 Days – 18 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: * Continuous analgesic and sedative endovenous treatment for at least 5 days * Invasive or non-invasive mechanical ventilation * Clinical conditions that allow by clinical judgment the start of analgosedation weaning * Post-natal age ≥ 7 days and PMA beyond the 37 weeks * Written informed consent obtained Exclusion Criteria: * Hemodynamic instability * Cardiac bundle-branch block of 2 or 3 degree * Hypersensitivity to the alpha-agonists * Persistent fever of unknown origin or sensitivity to malignant hyperthermia * Use of alpha-agonist (clonidine or dexmedetomidine) in the last 30 days

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

Change in Withdrawal Assessment Tool (WAT-1) scale

Timeframe: time 0 start dexmedetomidine and every 12 hours post-start dexmedetomidine for 7 days

Trial details

NCT IDNCT03645603

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-18

View on ClinicalTrials.gov More Withdrawal Syndrome trials