Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nebulization of dexmedetomidine and ketamine, Nebulization of dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Sedation, Emergence Delirium. Basic parameters: 12 months — 48 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
Overview
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
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.
Interventions
- Drug Nebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine - Drug Nebulization of dexmedetomidine
Pre-operative nebulization of dexmedetomidine
Primary outcome measures
- University of Michigan Sedation Scale (UMSS) [Time frame: Pre-operative]
Secondary outcome measures (2)
- Parental Separation using the Parenteral Separation Anxiety Scale (PSAS) [Time frame: Pre-operative]
- Watcha scale for emergence delirium [Time frame: Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Assiut University — Asyut
Identifiers
NCT: NCT05821972 · Dexmedetomidine Ketamine