Nebulized dexmedetomidine with ketamine versus dexmedetomidine alone for sedation in children having cleft palate repair
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
This will test whether adding ketamine to nebulized dexmedetomidine helps sedate children undergoing cleft palate repair and reduces emergence delirium.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Months to 48 Months |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT05821972 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children ASA I–II scheduled for primary cleft palate repair who have no major organ disease, no asthma or psychiatric illness, and no allergy to dexmedetomidine or ketamine.
Not a fit: Children with significant cardiac, renal, hepatic, or endocrine disease, asthma, psychiatric disorders, suspected difficult airway, or known allergy to the drugs are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding ketamine to nebulized dexmedetomidine could provide quicker, more stable preoperative sedation and lower the risk of emergence delirium without respiratory depression.
How similar studies have performed: Dexmedetomidine is widely used for pediatric premedication and small studies suggest ketamine can complement it, but nebulized ketamine-dexmedetomidine combinations for cleft palate premedication are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Asyut
- Assiut University — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Fatma N. Mohamed, M.D.
- Email: fatmanabil2012@aun.edu.eg
- Phone: +201003633992
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.