Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

September 30, 2025 updated by: FATMA NABIL AHMED MOHAMED, Assiut University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt, 71515
        • Recruiting
        • Assiut University
        • Contact:
        • Contact:
          • Samar A Abdellah
          • Phone Number: +201095769703
        • Principal Investigator:
          • Mohammed Galal, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
Drug: Nebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
Active Comparator: Nebulized dexmedetomidine
Pre-operative nebulization of dexmedetomidine
Drug: Nebulization of dexmedetomidine
Pre-operative nebulization of dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
University of Michigan Sedation Scale (UMSS)
Time Frame: Pre-operative
It ranges from 0 = awake, alert to 4 = unarousable
Pre-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

October 20, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexmedetomidine Ketamine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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