a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients

King Faisal Specialist Hospital & Research Center

Status and phase: Enrolling; Phase 3

Conditions: Perioperative/Postoperative Complications; Anxiety State

Treatments: Drug: Dexmedetomidine; Drug: Midazolam; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04356638

2191310

Details and patient eligibility

About

This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH&RC standard of care. Compare the safety and the frequency of adverse effects of treatment arms.

Enrollment: 80 estimated patients

Sex: All

Ages: 12 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital & Research Center (KFSH&RC) age 1-12 years

Exclusion criteria

• Weight ≥ 40 kilograms
• Allergies to the study drug
• Refused to take the study drug
• Severe learning disability
• Patient on Digoxin medication
• Patient on beta-blocker medication
• Cardiac disease with abnormal conduction system
• Nasal anatomical abnormality

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

The sedative pre-medication oral Midazolam

Active Comparator group

Treatment:

Drug: Midazolam

The sedative pre-medication intranasal Dexmedetomidine

Active Comparator group

Treatment:

Drug: Dexmedetomidine

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

No Sedative Pre-medication

No Intervention group