Midazolam‑Ketamine versus Dexmedetomidine to prevent emergence delirium after deep sedation in children with burns
The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn Patients
We will try whether a midazolam‑ketamine combination or dexmedetomidine better prevents emergence delirium in children aged 3–16 undergoing deep sedation for burn dressing changes or minor procedures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07519863 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled Phase 2 study that assigns eligible pediatric burn patients to either an intravenous midazolam‑ketamine combination or intravenous dexmedetomidine for standardized deep sedation. Sedation depth will be kept comparable between groups using a validated sedation scale and standard intraoperative monitoring. Emergence delirium will be measured after the procedure using the Pediatric Anesthesia Emergence Delirium (PAED) scale as the primary outcome. Secondary outcomes include hemodynamic stability, recovery profile, postoperative pain scores, need for rescue medications, and adverse events.
Who should consider this trial
Good fit: Children aged 3–16 years with ASA physical status I–II who are scheduled for elective burn dressing changes or minor interventions and have no significant hepatic, renal, immunological, hematological, or neurological disorders are ideal candidates.
Not a fit: Patients with hepatic or renal dysfunction, immunological/hematological disorders, epilepsy, developmental delay or neurological deficits, preoperative hemodynamic instability, need for high‑dose inotropes/vasopressors, or known allergy to the study drugs are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the preferred sedation approach could reduce the incidence of emergence delirium and improve recovery comfort and safety for children having burn procedures.
How similar studies have performed: Prior pediatric anesthesia studies have shown dexmedetomidine can reduce emergence delirium compared with some traditional sedatives, but direct comparisons with a midazolam‑ketamine combination specifically in burn deep sedation are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Exclusion Criteria: * 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
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.