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.

Dexmedetomidine Clinical Trial

— PROMISE  

Official title:

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 (PICU) at KASCH-MNGHA.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485519
• Other study ID #: RC20/160/R
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Dexmedetomidine
• Midazolam
• Substance Withdrawal Syndrome
• Withdrawal Symptoms

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