Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Phase 4

Recruiting

• Conditions: Sedation; Emergence Delirium
• Interventions: Drug: Nebulization of dexmedetomidine and ketamine; Drug: Nebulization of dexmedetomidine

• Registration Number: NCT05821972
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Study Start: 2024-04-10
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-03
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized dexmedetomidine and ketamine	Nebulization of dexmedetomidine and ketamine	Pre-operative nebulization of dexmedetomidine and ketamine
Nebulized dexmedetomidine	Nebulization of dexmedetomidine	Pre-operative nebulization of dexmedetomidine

Primary Outcome Measures

Name	Time	Method
University of Michigan Sedation Scale (UMSS)	Pre-operative	It ranges from 0 = awake, alert to 4 = unarousable

Secondary Outcome Measures

Name	Time	Method
Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)	Pre-operative	It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.
Watcha scale for emergence delirium	Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.	It ranges from 1= calm to 4 = agitated

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Asyut, Egypt