The Randomized Double-Blind Comparison of Analgesic Efficacy Between Intravenous Forms of Ibuprofen 400 and Ibuprofen 800 mg in Acute Mechanical Low Back Pain in the Emergency Department

Low Back Pain Analgesic

The Management of Low Back Pain in the Emergency Department Worldwide, low back pain is one of the most prevalent musculoskeletal disorders, and it constitutes one of the primary complaints in emergency departments. A review of the literature reveals studies comparing ibuprofen to various agents (such as paracetamol, nimesulide, acetaminophen), and these studies suggest the use of ibuprofen due to its similar or superior efficacy and its safety profile. However, there is a lack of randomized controlled double-blind comparisons between the commonly recommended single doses of ibuprofen, which are 400 mg and 800 mg. Therefore, the objective of our planned study is to compare the analgesic efficacy of ibuprofen in the forms of 400 mg and 800 mg, which can be administered as a single dose, in the treatment of acute mechanical low back pain, as recommended in all guidelines.

2022-01-01

2022-12-31

2023-03-01

Completed

Early phase I

144

Inclusion Criteria: * Patients aged 18 and above but under 65 years old. * Patients willing to participate in the study. * Patients with acute pain lasting less than two weeks. * Non-traumatic pain. * Patients without radicular back pain. * Patients scoring more than 5 points on the 24-item validated Roland Morris Disability Questionnaire (RMDQ). * Patients marking more than 4 on the Numeric Pain Rating Scale (NRS). * Patients deemed appropriate for the study by an emergency medicine specialist based on history and physical examination. * Patients in whom other differential diagnoses are not primarily considered. Exclusion Criteria: * - Patients aged below 18 and above 65. * Patients who decline to participate in the study. * Patients with vital signs outside normal limits. * Patients with a history of adverse reactions to ibuprofen. * Patients unable to determine their pain intensity on the NRS. * Pregnant individuals. * Individuals with a history of heart disease and hypertension. * Individuals with advanced systemic diseases. * Patients with malignancies. * Patients with chronic liver disease. * Individuals using neuro-psychiatric drugs with sedative and analgesic effects. * Individuals with a history of psychological and neurological diseases. * Patients who used analgesics within 6 hours before examination. * Patients with pain lasting more than two weeks. * Traumatic cases.

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2023-10-03