Condition: Cleft Lip Palate · Orofacial Cleft · Agitation, Emergence · Sponsor: Iva Smiljanić
Orofacial clefts are among the most common congenital malformations, affecting approximately 1 in 700-1500 live births worldwide. They are associated not only with aesthetic concerns but also with functional impairments in feeding, speech, hearing, and dentition, and may be accompanied by other systemic malformations, often requiring multiple surgical procedures and long-term multidisciplinary care. Although cognitive development is preserved, the psychosocial impact on both children and families can be significant. Anesthesia in children with clefts presents specific challenges. Airway management is often more difficult due to anatomical variations, particularly in syndromic patients and those under 1 year of age. Immature organ systems affect drug metabolism, requiring careful dose adjustment. Preoperative anxiety and stress responses are common and may contribute to complications such as laryngospasm and bronchospasm. In the postoperative period, emergence agitation (EA) and emergence delirium (ED) are frequent, with reported incidence up to 80%. These conditions are characterized by restlessness, inconsolability, and disorientation, and may result in self-injury or disruption of surgical repairs. Differentiating agitation from pain is challenging in young children due to limited communication abilities. Validated observational tools such as CHIPPS, PAEDS, and Cravero scales are used for routine clinical assessment of pain and EA/ED, although their subjective nature may …
This description comes directly from the study's public registry record.
Iva SMILJANIĆ, MD, MSc · +385915406518 · iva.smiljanic@yahoo.com
Predrag Knežević, MD, Professor · +385 91 539 5202 · pknezev@kbd.hr
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| University Hospital Dubrava | Zagreb, Croatia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07557576