Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

NCT ID: NCT05821972

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Sedation Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nebulized dexmedetomidine and ketamine

Pre-operative nebulization of dexmedetomidine and ketamine

Group Type EXPERIMENTAL

Nebulization of dexmedetomidine and ketamine

Intervention Type DRUG

Pre-operative nebulization of dexmedetomidine and ketamine

Nebulized dexmedetomidine

Pre-operative nebulization of dexmedetomidine

Group Type ACTIVE_COMPARATOR

Nebulization of dexmedetomidine

Intervention Type DRUG

Pre-operative nebulization of dexmedetomidine

Interventions

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Nebulization of dexmedetomidine and ketamine

Pre-operative nebulization of dexmedetomidine and ketamine

Intervention Type DRUG

Nebulization of dexmedetomidine

Pre-operative nebulization of dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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FATMA NABIL AHMED MOHAMED

Clinical Supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fatma N. Mohamed, M.D.

Role: CONTACT

+201003633992

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

Role: CONTACT

+201095769703

Facility Contacts

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Fatma N. Mohamed, M.D.

Role: primary

+201003633992

Samar A Abdellah

Role: backup

+201095769703

Other Identifiers

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Dexmedetomidine Ketamine

Identifier Type: -

Identifier Source: org_study_id

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