Actively Recruiting
Led by Iva Smiljanić · Updated on 2026-04-29
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
I
Iva Smiljanić
Lead Sponsor
U
University of Zagreb
Collaborating Sponsor
Orofacial clefts are common birth defects affecting about 1 in 700 to 1500 live births worldwide. These clefts impact feeding, speech, hearing, and teeth, and often require multiple surgeries and long-term care. While cognitive development is usually normal, the condition can cause significant emotional and social challenges for children and families. Anesthesia in these children is difficult due to airway differences and immature organ systems, which affect drug processing. Postoperative problems like emergence agitation and delirium, which involve restlessness and confusion, are common and can lead to injury or surgical disruption. This clinical trial compares opioid-based anesthesia using fentanyl with an opioid-free protocol using ketamine and dexmedetomidine in children aged 3 months to 7 years undergoing cleft lip or palate surgery. Both groups also receive propofol, vecuronium, sevoflurane, and nitrous oxide. The surgeries are done in the morning to reduce biomarker variation, and blood samples are taken before anesthesia induction and before awakening. Some children undergoing multiple surgeries will receive both anesthesia types at different times to compare effects within the same patient. Participants will be monitored for postoperative pain using the CHIPPS scale and for emergence agitation using the PAEDS and Cravero scales at specific times up to 24 hours after surgery. Blood tests will measure stress markers like cortisol, alpha-amylase, and neuropeptide Y. Researchers will also track side effects such as nausea, vomiting, and breathing problems. Pain relief after surgery includes paracetamol and NSAIDs, with fentanyl available if needed. The study aims to find if opioid-free anesthesia offers better pain control, less agitation, and fewer side effects in children having cleft surgery.
CONDITIONS
Effect of Opioid-Free vs Opioid-Based Anesthesia on Postoperative Pain and Emergence Agitation in Children Undergoing Cleft Surgery
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Surgical procedure day plus 24 hours postoperatively
Participants undergo cleft lip and/or palate surgery under either opioid-free anesthesia using ketamine and dexmedetomidine or opioid-based anesthesia using fentanyl, along with standard anesthetic agents. Postoperative pain and emergence agitation are closely monitored.
1 surgical visit with continuous monitoring during anesthesia and 1 follow-up visit within 24 hours after surgery for pain and agitation assessments
Duration - 24 hours post-surgery
Participants are observed for postoperative adverse events and recovery over the first 24 hours after surgery, including monitoring of pain, agitation, and any side effects or complications related to anesthesia.
Multiple assessments within 24 hours postoperatively in the hospital ward
Total: 1 location
1
University Hospital Dubrava
Zagreb, Croatia, 10000
Actively Recruiting
I
Iva SMILJANIĆ, MD, MSc
P
Predrag Knežević, MD, Professor
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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