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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. (PROMISE)

K

King Abdullah International Medical Research Center

Status and phase

Enrolling
Phase 3

Conditions

Failure of Extubation
Withdrawal Symptoms
Dexmedetomidine
Midazolam

Treatments

Drug: Midazolam
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT05485519
RC20/160/R

Details and patient eligibility

About

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.

Full description

Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.

Enrollment

430 estimated patients

Sex

All

Ages

1 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 1-14 years both male and female who require mechanical ventilation
  2. 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.
  3. Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

430 participants in 2 patient groups

Dexmedetomidine (D)
Experimental group
Description:
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Treatment:
Drug: Dexmedetomidine
Midazolam (M)
Active Comparator group
Description:
1 mcg/kg/minute. Up to a maximum of 5 mcg/kg/minute.
Treatment:
Drug: Midazolam

Trial contacts and locations

1

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Central trial contact

Majed A Jeraisy

Data sourced from clinicaltrials.gov

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