Emergence Delirium in Pediatric AnesthesiaPhase 2NCT07519863
The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
A Phase 2 study testing Midazolam + Ketamine and Dexmedetomidine (DEX) in people with Emergence Delirium in Pediatric Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effects of dormicum-ketamine versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Emergence Delirium in Pediatric Anesthesia
- What is being tested?
- Midazolam + Ketamine and Dexmedetomidine (DEX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to Dec 2026
- Phase
- Phase 2
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 3 to 16 years
- Both sexes
- Patients classified as American Society of Anesthesiologists (ASA) Physical -Status I-II
- Patients scheduled for elective burn-related procedures (e.g., burn dressing changes or minor interventions)
Who cannot join
- Refusal or inability to provide written informed consent from parent or legal guardian
- Known allergy or hypersensitivity to any of the study medications (midazolam, ketamine, or dexmedetomidine)
- Presence of hepatic dysfunction
- Presence of renal dysfunction
- Presence of immunological or hematological disorders
- History of epilepsy, developmental delay (mental retardation), or neurological deficits
- Patients receiving or requiring high doses of inotropes and/or vasopressors intraoperatively or postoperatively
- Preoperative hemodynamic instability, defined as uncontrolled hypertension, hypotension, or bradycardia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Hebatalla M Ahmed, Masters degree, 00201155859990, hebatallamaged@med.asu.edu.eg
Hebatalla M Ahmed, Masters Degree
About this study
The aim of this study is to compare the effects of dormicum-ketamine versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures
Read the detailed description
This prospective randomized controlled study aims to compare the effects of a midazolam-ketamine combination versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures. Eligible pediatric burn patients scheduled for elective dressing changes or minor interventions will be randomly assigned into two equal groups.
Group I (Midazolam-Ketamine group) will receive intravenous midazolam combined with ketamine for deep sedation.
Group II (Dexmedetomidine group) will receive intravenous dexmedetomidine-based sedation according to a standardized dosing protocol.
Standard monitoring will be applied throughout the procedure, and sedation depth will be assessed using a validated sedation scale to ensure comparable levels of deep sedation in both groups. Emergence delirium will be evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale during recovery.
The primary outcome will be the incidence of emergence delirium in the early postoperative period. Secondary outcomes will include hemodynamic stability, recovery profile, postoperative pain scores, need for rescue medications, and incidence of adverse events.
- Being tested
- Midazolam + Ketamine, Dexmedetomidine (DEX)
- Keywords
- Dexmedetomidine, Burn Procedural sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam + KetamineDrug
Participants will receive intravenous midazolam (0.05 mg/kg) combined with ketamine (1 mg/kg). Supplemental ketamine doses (0.5 mg/kg) will be administered as needed to maintain adequate deep sedation during burn-related procedures.
Dexmedetomidine (DEX)Drug
Participants will receive intravenous dexmedetomidine (loading dose 1 mcg/kg over 15 minutes, followed by infusion 0.5-1 mcg/kg/hour) adjusted to maintain adequate deep sedation during burn-related procedures.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam - Ketamine Group | Experimental | Drug Receives: Drug: Midazolam + Ketamine |
| Dexmedetomidine | Experimental | Drug Receives: Drug: Dexmedetomidine (DEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence delirium
Incidence of emergence delirium within 30 minutes after the end of anesthesia, defined as a Pediatric Anesthesia Emergence Delirium (PAED) Scale score ≥ 10 at any assessment point.
The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a validated instrument ranging from 0 to 20, where higher scores indicate more severe emergence delirium (worse outcome).
Measured: within 30 minutes after end of anesthesia
Secondary outcomes (3)
Total Opiod requirments
Reduction in perioperative opioid requirement (measured in µg/kg of fentanyl equivalent)
Measured: Perioperative period
Hemodynamic stability
Hemodynamic stability will be assessed by measuring heart rate (HR) and mean arterial pressure (MAP) at predefined time points.
Parameters will include:
Mean HR and MAP values Incidence of bradycardia (HR < age-adjusted normal) Incidence of hypotension (MAP decrease >20% from baseline)
Measured: Baseline (pre-sedation), intraoperative period (every 5 minutes), and up to 30 minutes postoperatively
The duration of stay in PACU
The duration of stay in PACU
Measured: Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence Delirium in Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519863
- Sponsor's protocol ID
- FMASU MD389/2025
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
- ClinicalTrials.gov ID
- NCT07519863
- Acronym / sponsor ID
- FMASU MD389/2025
- Keywords
- Dexmedetomidine, Burn Procedural sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Apr 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.
The aim of this study is to compare the effects of dormicum-ketamine versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures
Detailed description
This prospective randomized controlled study aims to compare the effects of a midazolam-ketamine combination versus dexmedetomidine on postoperative emergence delirium in pediatric patients undergoing deep sedation for burn-related procedures. Eligible pediatric burn patients scheduled for elective dressing changes or minor interventions will be randomly assigned into two equal groups.
Group I (Midazolam-Ketamine group) will receive intravenous midazolam combined with ketamine for deep sedation.
Group II (Dexmedetomidine group) will receive intravenous dexmedetomidine-based sedation according to a standardized dosing protocol.
Standard monitoring will be applied throughout the procedure, and sedation depth will be assessed using a validated sedation scale to ensure comparable levels of deep sedation in both groups. Emergence delirium will be evaluated postoperatively using the Pediatric Anesthesia Emergence Delirium (PAED) scale during recovery.
The primary outcome will be the incidence of emergence delirium in the early postoperative period. Secondary outcomes will include hemodynamic stability, recovery profile, postoperative pain scores, need for rescue medications, and incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam - Ketamine Group | Experimental | Drug: Midazolam + KetamineDrug |
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine (DEX)Drug |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 3 to 16 years
- Both sexes
- Patients classified as American Society of Anesthesiologists (ASA) Physical -Status I-II
- Patients scheduled for elective burn-related procedures (e.g., burn dressing changes or minor interventions)
Key exclusion criteria (8 listed)
- Refusal or inability to provide written informed consent from parent or legal guardian
- Known allergy or hypersensitivity to any of the study medications (midazolam, ketamine, or dexmedetomidine)
- Presence of hepatic dysfunction
- Presence of renal dysfunction
- Presence of immunological or hematological disorders
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 |
|---|---|---|
| Midazolam + KetamineParticipants will receive intravenous midazolam (0.05 mg/kg) combined with ketamine (1 mg/kg). Supplemental ketamine doses (0.5 mg/kg) will be administered as needed to maintain adequate deep sedation during burn-related procedures. | Drug | Midazolam - Ketamine Group |
| Dexmedetomidine (DEX)Participants will receive intravenous dexmedetomidine (loading dose 1 mcg/kg over 15 minutes, followed by infusion 0.5-1 mcg/kg/hour) adjusted to maintain adequate deep sedation during burn-related procedures. | Drug | Dexmedetomidine |
Primary outcome
Incidence of emergence delirium
Time frame: within 30 minutes after end of anesthesia
Incidence of emergence delirium within 30 minutes after the end of anesthesia, defined as a Pediatric Anesthesia Emergence Delirium (PAED) Scale score ≥ 10 at any assessment point. The Pediatric Anesthesia Emergence Delirium (PAED) Scale is a validated instrument ranging from 0 to 20, where higher scores indicate more severe emergence delirium (worse outcome).
3 secondary outcomes
Total Opiod requirments
Time frame: Perioperative period
Hemodynamic stability
Time frame: Baseline (pre-sedation), intraoperative period (every 5 minutes), and up to 30 minutes postoperatively
The duration of stay in PACU
Time frame: Within 30 minutes after the end of anesthesia, with assessment performed during recovery ( every 5 minutes)
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 9 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Midazolam + Ketamine and Dexmedetomidine (DEX) in people with Emergence Delirium in Pediatric Anesthesia, run by Ain Shams 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 4 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: looking for participants now, as of the sponsor's last update on 9 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence delirium (time frame: within 30 minutes after end of 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 9 Apr 2026.