Analgesia Clinical Trial
Official title:
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
Verified date | September 2023 |
Source | Ankara City Hospital Bilkent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | March 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara City Hospital Bilkent |
Turkey,
Friedman BW, Irizarry E, Chertoff A, Feliciano C, Solorzano C, Zias E, Gallagher EJ. Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Low Back Pain: An Emergency Department-based Randomized Study. Acad Emerg Med. 2020 Mar;27(3):229-235. doi: 10.1111/acem.13898. Epub 2020 Jan 7. — View Citation
Oliveira IS, Vanin AA, Pena Costa LO, Medeiros FC, Ananias Oshima RK, Inacio AA, Matos da Cunha TA, Palomo AS, Fukuda TY, de Freitas DG, Benvenuto F, Menezes Costa LDC. Profile of Patients With Acute Low Back Pain Who Sought Emergency Departments: A Cross-sectional Study. Spine (Phila Pa 1976). 2020 Mar 1;45(5):E296-E303. doi: 10.1097/BRS.0000000000003253. — View Citation
Ostojic P, Radunovic G, Lazovic M, Tomanovic-Vujadinovic S. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study. Acta Reumatol Port. 2017 Jan-Mar;42(1):18-25. — View Citation
Pohjolainen T, Jekunen A, Autio L, Vuorela H. Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen. Spine (Phila Pa 1976). 2000 Jun 15;25(12):1579-85. doi: 10.1097/00007632-200006150-00019. — View Citation
Tuzun F, Unalan H, Oner N, Ozguzel H, Kirazli Y, Icagasioglu A, Kuran B, Tuzun S, Basar G. Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain. Joint Bone Spine. 2003 Sep;70(5):356-61. doi: 10.1016/s1297-319x(03)00075-7. — View Citation
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Primary | NRS | Numeric Rating Scale | 15., 30., 60. and 120. minutes |
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