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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
Oral Midazolam and intranasal placebo
Intranasal Dexmedetomidine and oral placebo
Placebo orally and intranasally
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
RECRUITINGAnxiety 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 Minutes
Visual Analog Scale for child anxiety
The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed
Time frame: 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
Time frame: 10 Minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Likert scale assessment of how cooperative/easy to handle the child
This will be measured when the IV cannulation is completed
Time frame: 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
Time frame: 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
Time frame: Day 2 post procedure