Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

NCT05821972 | Recruiting Phase 4

• 1 other identifier: Dexmedetomidine Ketamine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Emergence Delirium

Keywords

dexmedetomidine; Ketamine; Nebulization; Cleft palate; Sedation; Emergence delirium

Outcome Measures

Primary Outcomes (1)

• University of Michigan Sedation Scale (UMSS)

  It ranges from 0 = awake, alert to 4 = unarousable

  Pre-operative

Secondary Outcomes (2)

• Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)

  Pre-operative

• Watcha scale for emergence delirium

  Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.

Study Arms (2)

Nebulized dexmedetomidine and ketamine

EXPERIMENTAL

Pre-operative nebulization of dexmedetomidine and ketamine

Drug: Nebulization of dexmedetomidine and ketamine

Nebulized dexmedetomidine

ACTIVE COMPARATOR

Pre-operative nebulization of dexmedetomidine

Drug: Nebulization of dexmedetomidine

Interventions

Nebulization of dexmedetomidine and ketamine DRUG

Pre-operative nebulization of dexmedetomidine and ketamine

Nebulized dexmedetomidine and ketamine

Nebulization of dexmedetomidine DRUG

Pre-operative nebulization of dexmedetomidine

Nebulized dexmedetomidine

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Cleft Palate

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Fatma N. Mohamed, M.D.

CONTACT

+201003633992; fatmanabil2012@aun.edu.eg

Samar Ah. Abdellah, M.B.B.Ch.

CONTACT

+201095769703; samarahmed1810@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Supervisor

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 20, 2023
• Study Start: April 10, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

EG (1)