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Compares treatment options for Emergence Delirium in Pediatric Anesthesia
Official title The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
ClinicalTrials.gov ID: NCT07519863
What this study is testing
What is Midazolam + Ketamine?
Midazolam + Ketamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for emergence delirium in pediatric anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 16
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.