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)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Withdrawal Symptoms; Midazolam; Failure of Extubation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 430
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Majed A Jeraisy; Phone Number: 94455 +966-504192291; Email: jjeraisym@ngha.med.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 14611
    • Recruiting
    • King Abdullah Specialist Children Hospital (KASCH)
    • Contact: Majed Jeraisy; Phone Number: 0504192291; Email: JeraisyM@MNGHA.MED.SA
    • Principal Investigator: Majed A Jeraisy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To compare length of PICU stay in both groups	from Intubation to discharge assessed up to 1 month

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Midazolam; Intubation; Withdrawal Symptoms; failure of Extubating
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: RC20/160/R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No