Opioid-free versus opioid-based anesthesia for children having cleft lip or palate repair
Official title: Comparison of Impact of Opioid and Non-Opioid Anesthesia on Pain and Agitation Levels in Children After Cleft Lip and Palate Surgery
Run by University of Zagreb · NCT07557576 · Data updated 2026-11-12
This will test whether opioid-free anesthesia can control pain and reduce emergence agitation in children undergoing cleft lip or palate repairs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Months to 7 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Status | Recruiting |
| Started | May 16, 2024 |
| Main results expected | August 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07557576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children undergoing elective cleft lip or palate repair who are ASA physical status I–II, weigh more than 5 kg, meet the age thresholds for the procedure (≥3 months for lip, ≥9 months for palate), and have hemoglobin >100 g/L without recent respiratory infection.
✕Probably not a fit
Children who are ASA III–IV, weigh less than 5 kg, do not meet the minimum age thresholds, have hemoglobin <100 g/L, have recent respiratory infection or require perioperative intensive care are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children eligible for cleft lip or palate repair (ASA I–II, weight >5 kg, age ≥3 months for lip repair and ≥9 months for palate repair) receive either an opioid-free anesthetic regimen using agents such as ketamine and dexmedetomidine with propofol/sevoflurane or a conventional opioid-based regimen using fentanyl with propofol/sevoflurane. Doses are adjusted by weight and age and the dexmedetomidine infusion is titrated according to protocol while intraoperative monitoring follows standard practice. Postoperative outcomes including pain scores, incidence and severity of emergence agitation, and immediate recovery parameters are recorded in the PACU. The procedures and follow-up are performed at University Hospital Dubrava in Zagreb under institutional perioperative care pathways.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative pain and emergence agitation while decreasing opioid exposure and its side effects in children having cleft surgery.
How similar studies have gone: Previous pediatric trials and reports of opioid-sparing or opioid-free anesthesia have shown reductions in emergence agitation and opioid-related side effects in some settings, but results have been mixed and dependent on drugs, dosing, and patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA physical status I-II * Body weight \>5 kg * Age ≥3 months for cleft lip repair and ≥9 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
Where it's running
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University Hospital Dubrava
Zagreb, Croatia Recruiting
Study contacts
- Principal investigator: Iva Smiljanic, MD, MSc — University Hospital Dubrava, Zagreb
- Study coordinator: Iva SMILJANIĆ, MD, MSc
- Email: iva.smiljanic@yahoo.com
- Phone: +385915406518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.