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Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

NCT05288374 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-02-07

No results posted yet for this study

Summary

Patients scheduled for elective osteosynthesis of the distal radius will be randomized to receive celecoxib 100 mg orally (PO) at 6 in the morning before surgery and every 12 hours for 2 days thereafter, or a placebo pill in the same regimen. After surgery under general anaesthesia, they will receive paracetamol 1 g intravenously (IV) every 6 hours and if pain intensity is greater than 4 on a numeric rating scale (NRS) of 0-10, piritramid 15 mg intramuscularly (IM) will be administered. Pain intensity, piritramid consumption and side effects of treatment will be recorded in a questionnaire for 2 days.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Celecoxib 100 mg

Administering Celecoxib 100 mg (Celebrex) regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery

DRUG

Placebo

Administering placebo regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    collaborator OTHER_GOV

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Jiří Málek, MD · 3rd Medical Faculty of Charles University and Faculty Hospital Kralovske Vinohrady

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288374 on ClinicalTrials.gov