Anxiety State, Perioperative/Postoperative Complications
Conditions
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.
Interventions
DRUGMidazolam
Oral Midazolam and intranasal placebo
DRUGDexmedetomidine
Intranasal Dexmedetomidine and oral placebo
OTHERPlacebo
Placebo orally and intranasally
Sponsors
King Faisal Specialist Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Level | 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). |
| Safety - Hemodynamic stability | 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 | 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. |
| Oxygen saturation | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for child anxiety | 10 Minutes | The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed |
| Post Hospitalization Behavior Questionnaire for Ambulatory Surgery | Day 2 post procedure | A two day post assessment will be completed by interviewing the parents about changes in behavior derived from the questionnaire |
| IV cannulation procedure completion and number of attempts - yes or no | 10 Minutes | This will be measured when the IV cannulation procedure is successful or not |
| Likert scale assessment of how cooperative/easy to handle the child | 10 Minutes | This will be measured when the IV cannulation is completed |
| Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects | 60 Minutes | 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 |
Countries
Saudi Arabia
Contacts
Primary ContactLars Engborg, MD
Backup ContactDean Turina, MD BSc
Outcome results
None listed