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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anxiety State, Perioperative/Postoperative Complications

Intervention / Treatment
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* Drug: Midazolam
* Drug: Dexmedetomidine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The sedative pre-medication oral Midazolam<br> | Drug: Midazolam<br>* Oral Midazolam and intranasal placebo<br>|
| Active Comparator: The sedative pre-medication intranasal Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Intranasal Dexmedetomidine and oral placebo<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo orally and intranasally<br>|
| No Intervention: No Sedative Pre-medication<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Level | 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). | 30 Minutes | 
| Safety - Hemodynamic stability | 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. | 30 Minutes | 
| Safety - Respiratory function | 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. | 30 Minutes | 
| Oxygen saturation | 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. | 30 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for child anxiety | The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed | 10 Minutes | 
| IV cannulation procedure completion and number of attempts - yes or no | This will be measured when the IV cannulation procedure is successful or not | 10 Minutes | 
| Likert scale assessment of how cooperative/easy to handle the child | This will be measured when the IV cannulation is completed | 10 Minutes | 
| Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects | This measurement will assess the emergence delirium of the participants when they have completed the MRI under general anesthesia - every 10 minutes until discharge from recovery room | 60 Minutes | 
| Post Hospitalization Behavior Questionnaire for Ambulatory Surgery | A two day post assessment will be completed by interviewing the parents about changes in behavior derived from the questionnaire | Day 2 post procedure |