Nebulized dexmedetomidine with ketamine versus dexmedetomidine alone for sedation in children having cleft palate repair

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 Phase 4 interventional comparison gives children scheduled for primary cleft palate repair a preoperative nebulized dose of either dexmedetomidine plus ketamine or dexmedetomidine alone. Participants are ASA I–II pediatric patients without major comorbidities and are monitored for sedation onset, hemodynamic effects, and emergence delirium postoperatively. Investigators record intraoperative and recovery room outcomes to compare effectiveness and side-effect profiles between the two nebulized regimens. The protocol excludes patients with suspected difficult airways, significant cardiac, hepatic, renal or endocrine disease, asthma, psychiatric disorders, or drug allergies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status I \& II who will be scheduled for cleft palate repair surgeries

Exclusion Criteria:

* Parent refusal
* Allergy to the study drugs
* Suspected difficult airway
* Patients with endocrine, renal, hepatic, and cardiac pathology
* Psychiatric diseases
* Asthmatic patients.

Where it's running

• Assiut University
  Asyut, Egypt Recruiting

Study contacts

• Study coordinator: Fatma N. Mohamed, M.D.
• Email: fatmanabil2012@aun.edu.eg
• Phone: +201003633992

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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.