Midazolam‑Ketamine versus Dexmedetomidine to prevent emergence delirium after deep sedation in children with burns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ain Shams University
  Cairo, Egypt Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Paedfusor and Eleveld propofol TCI versus sevoflurane for reducing wake-up agitation in children

  This project will test whether two propofol target-controlled infusion methods (Paedfusor and Eleveld) or sevoflurane inhalation better prevent awakening agitation in children aged 3–10 having planned urogenital surgery.

  Recruiting at 2 sites Marmara University Pendik Training and Research Hospital · Istanbul and 1 other locations · NCT07534956

• Greater auricular nerve block to reduce agitation after children's middle ear surgery

  This trial will test whether an ultrasound-guided greater auricular nerve block can reduce agitation and pain when children wake up after microscopic middle ear surgery.

  Recruiting Fayoum University · Al Fayyum, Faiyum Governorate · NCT07435675

• Personal versus hospital-provided dolls to comfort preschoolers during adenoidectomy or tonsillectomy

  This tests whether a child's own doll or a hospital-provided doll reduces preoperative anxiety and emergence delirium in 3–7-year-old girls having elective adenoidectomy or tonsillectomy.

  Recruiting Ankara City Hospital Bilkent · Ankara, ÇANKAYA · NCT07403773

• Ride-on toy car transfer for preschool boys going to the operating room

  This trial will see if moving boys aged 3–7 to the operating room in a ride-on toy car reduces preoperative anxiety and emergence delirium compared with a standard stretcher.

  Recruiting Ankara City Hospital Bilkent · Ankara · NCT07403747

• Propofol vs. Dexmedetomidine for Preventing Emergence Agitation in Children After Sevoflurane Anesthesia

  This trial tests whether a single dose of propofol or a single dose of dexmedetomidine, given after surgery, better prevents emergence agitation in children recovering from sevoflurane anesthesia.

  Recruiting Phase 4 Pakistan Institute of Medical Sciences · Islamabad, Federal · NCT07799311

• EEG versus BIS monitoring to reduce emergence delirium in young children under general anaesthesia

  This study will test whether using EEG or BIS monitoring during general anaesthesia helps reduce emergence delirium in children aged 1–6 having surgery.

  Recruiting University Hospital Ostrava · Ostrava, Moravian-Silesian Region · NCT07534215

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.