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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The sedative pre-medication oral Midazolam | Active Comparator |
| |
| The sedative pre-medication intranasal Dexmedetomidine | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| No Sedative Pre-medication | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Oral Midazolam and intranasal placebo |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Engborg, MD | Contact | +966555327987 | lengborg@kfshrc.edu.sa | |
| Dean Turina, MD BSc | Contact | +966500343041 | dturina8@kfshrc.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Ganesh Sivasankara, MBBS | King Faisal Specialist Hospital & Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & Research Center | Recruiting | Riyadh | Saudi Arabia |
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| Dexmedetomidine |
| Drug |
Intranasal Dexmedetomidine and oral placebo |
|
| Placebo | Other | Placebo orally and intranasally |
|
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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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