NCT07337629

Brief Summary

Reducing intra- and postoperative pain or using less opioids is an essential strategy in today's operations. One emerging and widely used method in this context is the use of preemptive analgesic medication. Paracetamol and ibuprofen used preemptively have been shown to reduce postoperative opioid use and pain scores. There are also studies showing that preemptive analgesia with different analgesic medications reduces opioid consumption and postoperative pain. Our study will evaluate both the intraoperative and postoperative effectiveness of paracetamol and ibupurofen with preemptive analgesia, considering total opioid use. It will also investigate drug side effects and their advantages using a 15-question compilation quality scale, validated in Turkish.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 24, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 2, 2026

Last Update Submit

January 2, 2026

Conditions

Keywords

SEPTORHİNOPLASTYPREEMPTİVEPARACETEMOLIBUPROFEN

Outcome Measures

Primary Outcomes (3)

  • ANALGESIA

    24-HOUR CUMULATIVE OPIOID CONSUMPTION

    24 HOURS

  • COMPILATION

    POSTOPERATIVE QUALITY OF RECOVERY-15 SCALE

    POSTOPERATIVE 24TH HOUR

  • PAIN SCORE

    PAIN WILL BE ASSESSED POSTOPERATIVELY AT 0, 1, 6, 12, and 24 HOURS, BOTH AT REST AND DURING ACTIVITY (COUGHING AND DEEP BREATHING), USING THE NRS (Numeric Rating Scale).

    24 HOURS

Study Arms (3)

GROUP P

PARACETEMOL

GROUP I

IBUPROFEN

GROUP K

CONTROL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PATIENTS UNDERGOING SEPTORINOPLASTY SURGERY

You may qualify if:

  • Septorhinoplasty surgery
  • ASA1-2 patients
  • Men and women aged 18-65
  • Informed consent and acceptance to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University Samsun Training and Research Hospital

Samsun, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Alshehri AA. Comparative Evaluation of Postoperative Pain Scores and Opioid Consumption in Septorhinoplasty After Administration of Single-Dose Preemptive Paracetamol and Ibuprofen: A Randomized Controlled Trial. Int Arch Otorhinolaryngol. 2023 Aug 4;27(3):e471-e477. doi: 10.1055/s-0042-1749386. eCollection 2023 Jul.

    PMID: 37564463BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hasan Cetinkaya, M.D.

    Samsun University Samsun Educational and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Cetinkaya, M.D.

CONTACT

Caner Genc, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

November 24, 2025

Primary Completion (Estimated)

November 24, 2026

Study Completion (Estimated)

November 24, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations