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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05485519
Other study ID # RC20/160/R
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 21, 2022
Est. completion date May 2024

Study information

Verified date April 2023
Source King Abdullah International Medical Research Center
Contact Majed A Jeraisy
Phone +966-504192291
Email jjeraisym@ngha.med.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 430
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 14 Years
Eligibility 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

Study Design


Intervention

Drug:
Dexmedetomidine
Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)
Midazolam
(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.

Locations

Country Name City State
Saudi Arabia King Abdullah Specialist Children Hospital (KASCH) Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms from end of sedation to extubation assessed up to 24 hrs
Secondary To compare length of PICU stay in both groups from Intubation to discharge assessed up to 1 month
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