Anxiety StatePhase 3NCT04356638
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
A Phase 3 study testing Midazolam and Dexmedetomidine in people with Anxiety State and Perioperative/Postoperative Complications, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 12 years
- Conditions the study is for
- Anxiety State, Perioperative/Postoperative Complications
- What is being tested?
- Midazolam and Dexmedetomidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Oct 2021to 30 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital \& Research Center (KFSH\&RC) age 1-12 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specialist Hospital & Research Center
Riyadh
Lars Engborg, MD, +966555327987, lengborg@kfshrc.edu.sa
Dean Turina, MD PhD, +96650034 3041, dturina81@kfshrc.edu.sa
About this study
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
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.
- Being tested
- Midazolam, Dexmedetomidine, Placebo
- Medical subject headings
- Anxiety Disorders, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Oral Midazolam and intranasal placebo
DexmedetomidineDrug
Intranasal Dexmedetomidine and oral placebo
PlaceboOther
Placebo orally and intranasally
| Study group | Role | What they receive |
|---|---|---|
| The sedative pre-medication oral Midazolam | Active comparator | Not described Receives: Drug: Midazolam |
| The sedative pre-medication intranasal Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| No Sedative Pre-medication | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 Minutes
Secondary outcomes (5)
Visual Analog Scale for child anxiety
The VAS will be measured when the subject enters the recovery room and when IV cannulation is performed
Measured: 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
Measured: 10 Minutes
Likert scale assessment of how cooperative/easy to handle the child
This will be measured when the IV cannulation is completed
Measured: 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
Measured: 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
Measured: Day 2 post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start17 Oct 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganesh Sivasankara, King Faisal Specialist Hospital & Research Center
- Investigators
- Ganesh Sivasankara, MBBS, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356638
- Sponsor's protocol ID
- 2191310
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2020
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04356638
- Acronym / sponsor ID
- 2191310
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The sedative pre-medication oral Midazolam | Active comparator | Drug: Midazolam |
| The sedative pre-medication intranasal Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Other: Placebo |
| No Sedative Pre-medication | No intervention | – |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All pediatric outpatients coming for MRI investigations requiring general anesthesia at King Faisal Specialist Hospital \& Research Center (KFSH\&RC) age 1-12 years
Key exclusion criteria (8 listed)
- Weight ≥ 40 kilograms
- Allergies to the study drug
- Refused to take the study drug
- Severe learning disability
- Patient on Digoxin medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamOral Midazolam and intranasal placebo | Drug | The sedative pre-medication oral Midazolam |
| DexmedetomidineIntranasal Dexmedetomidine and oral placebo | Drug | The sedative pre-medication intranasal Dexmedetomidine |
| PlaceboPlacebo orally and intranasally | Other | Placebo |
Primary outcome
Anxiety Level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Visual Analog Scale for child anxiety
Time frame: 10 Minutes
IV cannulation procedure completion and number of attempts - yes or no
Time frame: 10 Minutes
Likert scale assessment of how cooperative/easy to handle the child
Time frame: 10 Minutes
Assessment of the Pediatric Anesthesia Emergence Delirium (PAED-scale) for the subjects
Time frame: 60 Minutes
Post Hospitalization Behavior Questionnaire for Ambulatory Surgery
Time frame: Day 2 post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesh Sivasankara, MBBS principal investigator
King Faisal Specialist Hospital & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midazolam and Dexmedetomidine in people with Anxiety State and Perioperative/Postoperative Complications, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Engborg, MD (+966555327987, lengborg@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: 30 Minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.