Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Study Overview
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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.

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

Conditions
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Sedation, Emergence Delirium

Intervention / Treatment
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* Drug: Nebulization of dexmedetomidine and ketamine
* Drug: Nebulization of dexmedetomidine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) | It ranges from 0 = does not respond to a noxious stimulus, to 6 = Appears alert and awake and responds readily to name spoken in normal tone. the higher scores mean less sedation. | Pre-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Separation using the Parenteral Separation Anxiety Scale (PSAS) | It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome. | Pre-operative | 
| Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale | It ranges from 0 to 20. PAED score > 12 indicates the presence of emergence delirium with high sensitivity and specificity. | Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, Ketamine, Nebulization, Cleft palate, Sedation, Emergence delirium