UnknownPhase 3

Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.

Saudi Arabia430 participantsStarted 2022-04-21

Plain-language summary

Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.

Who can participate

Age range1 Year – 14 Years

SexALL

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Inclusion criteria

✓. Age 1-14 years both male and female who require mechanical ventilation
✓. Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required.
✓. Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours

Exclusion criteria

✕. Septic shock and/or multi-organ failure.
✕. Hemodynamically instability and requires inotropes.
✕. Severe intracranial or spinal trauma with high intracranial pressure
✕. Liver failure
✕. Acute or chronic renal failure.
✕. Glasgow Coma Scale (GCS) ≤8
✕. Known to have allergy to the study drugs

What they're measuring

Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms

Timeframe: from end of sedation to extubation assessed up to 24 hrs

Trial details

NCT IDNCT05485519

SponsorKing Abdullah International Medical Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05

Contact for this trial

Majed A Jeraisy

+966-504192291 jjeraisym@ngha.med.sa

View on ClinicalTrials.gov More Dexmedetomidine trials