Back to resultsa Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
Primary Purpose
Anxiety State, Perioperative/Postoperative Complications
Status
Recruiting
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Midazolam
Dexmedetomidine
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety State
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
Sites / Locations
- King Faisal Specialist Hospital & Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
No Intervention
Arm Label
The sedative pre-medication oral Midazolam
The sedative pre-medication intranasal Dexmedetomidine
Placebo
No Sedative Pre-medication
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
Secondary Outcome Measures
Visual Analog Scale for child anxiety
The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed
IV cannulation procedure completion and number of attempts - yes or no
This will be measured when the IV cannulation procedure is successful or not
Likert scale assessment of how cooperative/easy to handle the child
This will be measured when the IV cannulation is completed
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
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
Full Information
NCT ID
NCT04356638
First Posted
March 26, 2020
Last Updated
February 7, 2022
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04356638
Brief Title
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Perioperative/Postoperative Complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The sedative pre-medication oral Midazolam
Arm Type
Active Comparator
Arm Title
The sedative pre-medication intranasal Dexmedetomidine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
No Sedative Pre-medication
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Oral Midazolam and intranasal placebo
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Intranasal Dexmedetomidine and oral placebo
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo orally and intranasally
Primary Outcome Measure Information:
Title
Anxiety Level
Description
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
Title
Safety - Hemodynamic stability
Description
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
Title
Safety - Respiratory function
Description
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
Title
Oxygen saturation
Description
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
Secondary Outcome Measure Information:
Title
Visual Analog Scale for child anxiety
Description
The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed
Time Frame
10 Minutes
Title
IV cannulation procedure completion and number of attempts - yes or no
Description
This will be measured when the IV cannulation procedure is successful or not
Time Frame
10 Minutes
Title
Likert scale assessment of how cooperative/easy to handle the child
Description
This will be measured when the IV cannulation is completed
Time Frame
10 Minutes
Title
Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects
Description
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
Title
Post Hospitalization Behavior Questionnaire for Ambulatory Surgery
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Engborg, MD
Phone
+966555327987
Email
lengborg@kfshrc.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Dean Turina, MD BSc
Phone
+966500343041
Email
dturina8@kfshrc.edu.sa
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Engborg, MD
Phone
+966555327987
Email
lengborg@kfshrc.edu.sa
First Name & Middle Initial & Last Name & Degree
Dean Turina, MD PhD
Phone
+96650034 3041
Email
dturina81@kfshrc.edu.sa
12. IPD Sharing Statement
Learn more about this trial
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
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