Emergence DeliriumPhase 4NCT07427446
Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium
A Phase 4 study testing Dexmedetomidine and Midazolam and Ketamine and Midazolam in people with Emergence Delirium, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups. Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam) Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Dexmedetomidine and Midazolam and Ketamine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for elective cardiac catheterization under general anesthesia.
Who cannot join
- neurological disorder, psychiatric disease, or current psychoactive medication.
- allergy.
- significant systemic comorbidities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)
Read the detailed description
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) will receive dexmedetomidine 1 µg/kg IV over 10 minutes and midazolam 0.1 mg/kg IV as a bolus concomitant with induction, followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h and midazolam at 0.1 mg/kg/h for maintenance.
Group KM (Ketamine + Midazolam) will receive ketamine 1 mg/kg IV and midazolam 0.1 mg/kg IV as a bolus for induction, followed by a continuous infusion of ketamine at 1 mg/kg/h and midazolam at 0.1 mg/kg/h.
- Conditions
- Emergence Delirium
- Being tested
- Dexmedetomidine and Midazolam, Ketamine and Midazolam
- Keywords
- Emergence delirium, Dexmedetomidine, Ketamine, Midazolam, sevoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine and MidazolamDrug
Also called Precedex and Dormicum
Children will receive Dexamedetomedine and Midazolam
Ketamine and MidazolamDrug
Also called katalar and Dormicum
Children will receive Ketamine and Midazolam
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine-Midazolam | Active comparator | Children will receive Dexmedetomidine + Midazolam Receives: Drug: Dexmedetomidine and Midazolam |
| ketamine-Midazolam | Active comparator | Children will receive ketamine + Midazolam Receives: Drug: Ketamine and Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence delirium
Incidence of emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium PAED scale. The scale consists of five behavioral items, each rated on a 5-point scale from 0 to 4(Eye contact, Purposefulness, Awareness, Restlessness, Inconsolability),Total scores range from 0 to 20.A PAED score ≥10 will be considered a clinically significant ED.
Measured: 30 minutes post-anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
- Investigators
- Ahmed Elhaddad, Ass.prof., Principal investigator, Faculty of medicins,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427446
- Sponsor's protocol ID
- MS-664-2025
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07427446
- Acronym / sponsor ID
- MS-664-2025
- Conditions
- Emergence Delirium
- Keywords
- Emergence delirium, Dexmedetomidine, Ketamine, Midazolam, sevoflurane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Feb 2026 (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.
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)
Detailed description
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) will receive dexmedetomidine 1 µg/kg IV over 10 minutes and midazolam 0.1 mg/kg IV as a bolus concomitant with induction, followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h and midazolam at 0.1 mg/kg/h for maintenance.
Group KM (Ketamine + Midazolam) will receive ketamine 1 mg/kg IV and midazolam 0.1 mg/kg IV as a bolus for induction, followed by a continuous infusion of ketamine at 1 mg/kg/h and midazolam at 0.1 mg/kg/h.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine-Midazolam | Active comparator | Drug: Dexmedetomidine and MidazolamChildren will receive Dexmedetomidine + Midazolam |
| ketamine-Midazolam | Active comparator | Drug: Ketamine and MidazolamChildren will receive ketamine + Midazolam |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Scheduled for elective cardiac catheterization under general anesthesia.
Key exclusion criteria (3 listed)
- neurological disorder, psychiatric disease, or current psychoactive medication.
- allergy.
- significant systemic comorbidities.
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 |
|---|---|---|
| Dexmedetomidine and MidazolamAlso: Precedex and DormicumChildren will receive Dexamedetomedine and Midazolam | Drug | Dexmedetomidine-Midazolam |
| Ketamine and MidazolamAlso: katalar and DormicumChildren will receive Ketamine and Midazolam | Drug | ketamine-Midazolam |
Primary outcome
Emergence delirium
Time frame: 30 minutes post-anesthesia
Incidence of emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium PAED scale. The scale consists of five behavioral items, each rated on a 5-point scale from 0 to 4(Eye contact, Purposefulness, Awareness, Restlessness, Inconsolability),Total scores range from 0 to 20.A PAED score ≥10 will be considered a clinically significant ED.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ahmed Elhaddad, Ass.prof. principal investigator
Faculty of medicins,Cairo university
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 and Ketamine and Midazolam in people with Emergence Delirium, run by Kasr El Aini Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elhaddad, Ass.prof. (01224042847, drblacksmith@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence delirium (time frame: 30 minutes post-anesthesia). 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 27 Feb 2026.