Sciatica Clinical Trial
Official title:
Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial.
Currently, Paracetamol and Ibuprofen are widely used by emergency physicians in Turkey for
the pain treatments.
The objective of the study was to assess whether intravenous Paracetamol has superior
Sciatica pain reduction will compare with Ibuprofen in emergency department (ED) adults.
Half of the participants will receive Paracetamol and the other half will receive Ibuprofen.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients who presented with complaints of leg pain radiating the sciatic nerve tracings to the emergency services (Which may or may not be accompanied back pain), - Positive Laseque test identified patients in physical examination, - Patients whose complaints have started in the last week, - Younger than 21 years old, - Older than 65 years old. Exclusion Criteria: - Patients who have a leg or low back pain longer than a week Have a direct blunt trauma to the legs or lumbar area in the last week, - Pretreatment linear 100-mm visual analog scale (VAS) pain score less than 40 mm, - Patients who have drop foot, paralysis and other neurological symptoms in physical examination. - Patients with blood pressure less than 90mmHg in the arrival of emergency services. - Patients with malignancy, cauda equina syndrome, ankylosing spondylitis, rheumatoid arthritis or inflammatory arthritis contain any of the disease in his/her CV. - Patients with any history of chronic pain syndrome. - Patients who receive pain killers, antidepressants, anticonvulsants, muscle relaxants, steroids within 6 hours before the ED visit, - Patients with a history of Substance Dependence or alcohol abuse - Patients had a fever (>37.9) - Allergy or previous adverse reaction to the studied drugs(Ibuprofen, Paracetamol), received agents to inhibit the secretion of acid (PPIs or histamine-2 receptor antagonists), antispasmodics, or nonsteroidal anti-inflammatory drugs - were pregnant or breast-feeding, - inability to comprehend the VAS evaluation, - or refused to participate in the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University | Denizli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of Sciatica pain in Visual Analog Scale In 30 minutes. | this work tooks 6 mounts | Sciatica pain scores will be recorded at 0, 15, and 30 min. | No |
Secondary | Adverse events | 30 minutes after the study drug administered | 30 minutes after the drug administered. | No |
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