Opioid-free versus opioid-based anesthesia for children having cleft lip or palate repair
Comparison of Impact of Opioid and Non-Opioid Anesthesia on Pain and Agitation Levels in Children After Cleft Lip and Palate Surgery
This will test whether opioid-free anesthesia can control pain and reduce emergence agitation in children undergoing cleft lip or palate repairs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 3 Months to 7 Years |
| Sex | All |
| Sponsor | University of Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT07557576 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Zagreb
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.