DexmedetomidinePhase 4NCT04652661
Intranasal Dexmedetomidine Versus Intranasal Midazolam for MRI In Pediatrics
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Dexmedetomidine and Midazolam, run by Tanta University at 1 site in Egypt.
Trial summary
An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in… Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Dexmedetomidine, Midazolam, MRI
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2020to 1 Jan 2022
- Phase
- Phase 4
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.
Who cannot join
- Patient's guardian refusal.
- Body mass index >30 kg/m2
- Known allergy to dexmedetomidine or midazolam.
- Suspected difficult airway.
- Upper respiratory tract infection
- Anatomical structural deformity of the nasal cavity.
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- Severe liver or renal impairment.
- Severe bradycardia or atrioventricular block above II degree type 2.
- Administration of digoxin or beta blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial
An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.
Read the detailed description
This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.
Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:
Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
- Conditions
- Dexmedetomidine, Midazolam, MRI, Pediatrics
- Being tested
- Dexmedetomidine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
30 children will be sedated with 2 μg/kg intranasal DEX.
MidazolamDrug
30 children will be sedated with 0.3 mg/kg intranasal midazolam.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Experimental | 30 children will be sedated with 2 μg/kg intranasal dexmedetomidine Receives: Drug: Dexmedetomidine |
| Midazolam Group | Active comparator | 30 children will be sedated with 0.3 mg/kg intranasal midazolam. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of successful sedation
Successful sedation is defined as the time taken to achieve an MOAA/S score of 4 and is the time when the patients are calm and sedated and allow intravenous cannulation and MRI examination without crying or agitation.
Measured: One hour
Secondary outcomes (3)
The onset time of sedation
The onset time of sedation is defined as the time from drug administration to successful sedation.
Measured: One hour
The occurrence of Adverse effects
The occurrences of adverse events will be recorded (e.g. bradycardia, a significant oxygen saturation decrease, severe arrhythmia or arrest).
Measured: One hour
The degree of operator satisfaction
MRI operator satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start10 Dec 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes: Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taysser Mahmoud Abdalraheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652661
- Sponsor's protocol ID
- 32466/11/20
- Status last verified
- Apr 2023
- First submitted
- 26 Nov 2020
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be provided with a reasonable request from authors
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Versus Intranasal Midazolam as Sole Sedative Agents for MRI In Pediatrics: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT04652661
- Acronym / sponsor ID
- 32466/11/20
- Conditions
- Dexmedetomidine, Midazolam, MRI, Pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 3 Dec 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.
An increasing number of studies have reported the use of dexmedetomidine in clinical practice. However, few studies have reported on the intranasal use of dexmedetomidine in radiological procedures The aim of this work is to compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam in pediatrics undergoing MRI.
Detailed description
This prospective randomized double-blind clinical trial will be carried out on 60 children undergoing elective MRI in Tanta University Hospitals.
Sixty children will be randomly allocated into two equal groups by computer-generated sequence through sealed opaque envelopes:
Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Sixty children will be randomly allocated into two equal groups by computer generated sequence through sealed opaque envelopes: Group D: 30 children will be sedated with 2 μg/kg intranasal DEX. Group M: 30 children will be sedated with 0.3 mg/kg intranasal midazolam.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Experimental | Drug: Dexmedetomidine30 children will be sedated with 2 μg/kg intranasal dexmedetomidine |
| Midazolam Group | Active comparator | Drug: Midazolam30 children will be sedated with 0.3 mg/kg intranasal midazolam. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Aged from 2 to 8 years Both sexes ASA physical status I and II Elective MRI.
Key exclusion criteria (9 listed)
- Patient's guardian refusal.
- Body mass index >30 kg/m2
- Known allergy to dexmedetomidine or midazolam.
- Suspected difficult airway.
- Upper respiratory tract infection
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 |
|---|---|---|
| Dexmedetomidine30 children will be sedated with 2 μg/kg intranasal DEX. | Drug | Dexmedetomidine Group |
| Midazolam30 children will be sedated with 0.3 mg/kg intranasal midazolam. | Drug | Midazolam Group |
Primary outcome
The incidence of successful sedation
Time frame: One hour
Successful sedation is defined as the time taken to achieve an MOAA/S score of 4 and is the time when the patients are calm and sedated and allow intravenous cannulation and MRI examination without crying or agitation.
3 secondary outcomes
The onset time of sedation
Time frame: One hour
The occurrence of Adverse effects
Time frame: One hour
The degree of operator satisfaction
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No. The data will be provided with a reasonable request from authors
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Dexmedetomidine and Midazolam, run by Tanta University at 1 site in Egypt.
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 9 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: finished, as of the sponsor's last update on 20 Apr 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 Egypt. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of successful sedation (time frame: One hour). 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 20 Apr 2023.