One preoperative dose of paracetamol or ibuprofen to reduce opioids during and after septorhinoplasty
Comparison of the Effects of Single Dose Preemptive Paracetamol or Ibuprofen Administration Before Septrorhinoplasty on Intra- and Postoperative Opioid Consumption.
This project will test whether giving one dose of paracetamol or ibuprofen before septorhinoplasty cuts down opioid use during and after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsun University Academic / other |
| Locations | 1 site (Samsun) |
| Trial ID | NCT07337629 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational study using face-to-face interviews at the Ear, Nose and Throat Operating Room and Anesthesiology Clinic of Samsun University Training and Research Hospital. Patients scheduled for septorhinoplasty who meet inclusion criteria will receive preoperative paracetamol or ibuprofen and their intraoperative and postoperative opioid consumption will be recorded. The study will also track drug side effects and patient-reported outcomes using a validated 15-question Turkish quality scale. Enrollment is planned from November 1, 2025 through August 31, 2026 with a sample size increased above the minimum calculated 45 participants to allow for attrition.
Who should consider this trial
Good fit: Adults aged 18–65 with ASA physical status I–II scheduled for septorhinoplasty who can give informed consent and are not taking anticoagulants are ideal candidates.
Not a fit: Patients with serious renal, hepatic, cardiovascular or pulmonary disease, allergy to paracetamol or ibuprofen, bleeding disorders, pregnancy or current anticoagulant use are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could reduce the amount of opioid pain medication needed during and after septorhinoplasty and lower opioid-related side effects.
How similar studies have performed: Prior randomized and observational work has shown that preemptive paracetamol or NSAIDs can reduce postoperative opioid consumption and pain scores, so the approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Septorhinoplasty surgery * ASA1-2 patients * Men and women aged 18-65 * Informed consent and acceptance to participate in the study Exclusion Criteria: * ASA 3-4 and under 18 years of age * Patients with serious renal, hepatological, cardiovascular, or pulmonary system diseases * Allergy to paracetamol or ibuprofen * Patients with bleeding diathesis, platelet dysfunction, GI disease, peptic ulcers, pregnancy, planning pregnancy, and breastfeeding mothers * Patients using ASA or anticoagulants
Where this trial is running
Samsun
- Samsun University Samsun Training and Research Hospital — Samsun, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Hasan Cetinkaya, M.D. — Samsun University Samsun Educational and Research Hospital
- Study coordinator: Hasan Cetinkaya, M.D.
- Email: drhasancetinkaya@gmail.com
- Phone: 5464799240
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.