A Partially Double-Blinded, Randomized, Controlled, Placebo-Controlled Study, a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
Overview
- Phase
- Phase 3
- Intervention
- Midazolam
- Conditions
- Anxiety State
- Sponsor
- King Faisal Specialist Hospital & Research Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Safety - Hemodynamic stability
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Ganesh Sivasankara
Consultant, Anesthesiology
King Faisal Specialist Hospital & Research Center
Eligibility Criteria
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
Arms & Interventions
The sedative pre-medication oral Midazolam
Intervention: Midazolam
The sedative pre-medication intranasal Dexmedetomidine
Intervention: Dexmedetomidine
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety - Hemodynamic stability
Time Frame: 30 Minutes
The systolic and diastolic blood pressures will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Safety - Respiratory function
Time Frame: 30 Minutes
The respiratory rate will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Anxiety Level
Time Frame: 30 Minutes
Comparison of the level of anxiety as measured by The Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF) at the time when the child checks in at the front desk (say mYPAS-SF1), with when the attempt will be made to insert an IV line (say mYPAS-SF2). This scale is a score ranging from four (little anxiety) to twenty two (much anxiety).
Oxygen saturation
Time Frame: 30 Minutes
The SpO2 will be measured when the subject enters the recovery room, and then each ten minutes until the subject goes into the MRI suite and general anesthesia is induced.
Secondary Outcomes
- Visual Analog Scale for child anxiety(10 Minutes)
- IV cannulation procedure completion and number of attempts - yes or no(10 Minutes)
- Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects(60 Minutes)
- Post Hospitalization Behavior Questionnaire for Ambulatory Surgery(Day 2 post procedure)
- Likert scale assessment of how cooperative/easy to handle the child(10 Minutes)