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NCT Number: NCT05821972

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

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.

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Key information

Conditions

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

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University

Asyut, 71515, Egypt

Location status: Recruiting

Location contact

Fatma N. Mohamed, M.D.

CONTACT

[email protected]

+201003633992

Mohammed Galal, M.D.

PRINCIPAL_INVESTIGATOR

Samar A Abdellah

CONTACT

+201095769703

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nebulization of dexmedetomidine and ketamine

Drug

Pre-operative nebulization of dexmedetomidine and ketamine

Nebulization of dexmedetomidine

Drug

Pre-operative nebulization of dexmedetomidine

Primary outcomes

  1. University of Michigan Sedation Scale (UMSS)

    Time frame: Pre-operative

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

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma N. Mohamed, M.D.

CONTACT

[email protected]

+201003633992

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

CONTACT

[email protected]

+201095769703

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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