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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Pre-operative nebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine
Assiut University
Asyut, Egypt
RECRUITINGUniversity of Michigan Sedation Scale (UMSS)
It ranges from 0 = awake, alert to 4 = unarousable
Time frame: Pre-operative
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.
Time frame: Pre-operative
Watcha scale for emergence delirium
It ranges from 1= calm to 4 = agitated
Time frame: Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.
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