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โ† Trials
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Effect of Opioid-Free vs Opioid-Based Anesthesia on Postoperative Pain and Emergence Agitation in Children Undergoing Cleft Surgery

RecruitingNAAges 3 Months - 7 YearsAllIva Smiljaniฤ‡
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In plain words

What the trial is, and whether it could suit you

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 suc

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * ASA physical status I-II * Body weight \>5 kg * Age โ‰ฅ3 months for cleft lip repair and โ‰ฅ9 months for cleft palate repair * Hemoglobin \>100 g/L Exclusion Criteria: * ASA physical status III-IV * Body weight \<5 kg * Age \<3 months for cleft lip repair or \<9 months for cleft palate repair * Hemoglobin \<100 g/L * Acute illness * Respiratory infection or vaccination within 2 weeks prior to surgery * Requirement for perioperative intensive care
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What it tests

  • Ketamine (1 mg/kg)
  • Dexmedetomidine (1-0,8-0,6-0,4 mcg/kg/h)
  • Fentanyl 5 mcg/kg
  • Propofol (IV) 3-4 mg/kg
  • Sevoflurane (Volatile Anesthetic)
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Where

1 site
University Hospital Dubrava
Zagreb, Croatia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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