NCT05821972

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 12 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.

Detailed description

Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth. The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.

Conditions

• Sedation
• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Nebulization of dexmedetomidine and ketamine	Pre-operative nebulization of dexmedetomidine and ketamine
DRUG	Nebulization of dexmedetomidine	Pre-operative nebulization of dexmedetomidine

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-10-20
• Completion: 2025-10-30
• First posted: 2023-04-20
• Last updated: 2025-10-03

Locations

1 site across 1 country: Egypt