]>
IRCT20151113025025N2 IRCT 2018-09-30 Tehran University of Medical Sciences The comparison of the efficacy of intravenous ketorolac and ibuprofen in pain reduction in patients with acute low back pain presenting to the emergency department of Sina, Imam Khomeini and Shariati Hospitals in Tehran The comparison of the efficacy of intravenous ketorolac and ibuprofen in pain reduction in patients with acute low back pain presenting to the emergency department of Sina, Imam Khomeini and Shariati Hospitals in Tehran 2018-10-23 anticipated 80 Complete https://irct.ir/trial/33860 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Ketorolac and Ibuprofen ampules are prepared and placed in a 4 block sequence that is prepared by a nurse who knows the drug sequences according to a computerized random pattern but does not collect the results. These medications are restored in nearly 27 c in the emergency department. Then, the treating physician orders the next code analgesic from the block that will be infused according to the protocol we arranged. The treating physician documents the patients' demographic information and the diagnosis in the questionnaire form with the unique code of the medication that the patients received, Blinding description: This is a triple blind study (patient, researcher and data statistician) in a way that the two medications applied in this study are colorless, odorless and prepared with the same volume and infused to the patients so that they are indistinguishable. The medications are prepared by a nurse who is not involved in the treatment or gathering the research information and the random code of the infused medication will be documented in the questionnaires. The data analyzer will assess the encoded data and will not be informed of the medications. The analgesics of this study are as follows: - Intravenous Ibuprofen: The administration of 2 cc sterile water in 30 seconds and then, 800 mg Ibuprofen in 500 cc normal saline in 30 minutes. - Ketorolac: The administration of 30 mg Ketorolac in 2 cc syringe in 30 seconds and then, 500 cc normal saline in 30 minutes. 3 Acute low back pain. Intervention 1: Intervention group: Intravenous Ibuprofen. Intervention 2: Intervention group: Intravenous Ketorolac. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Anonymous data will be sent to a journal for the review process if needed.
public Maryam Bahreini
Emergency department, Sina hospital, Imam-Khomeini Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1136546911 +98 21 6312 1413 bahreinimaryam@gmail.com Tehran University of Medical Sciences scientific Maryam Bahreini
Emergency department, Sina hospital, Imam-Khomeini Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1136546911 +98 21 6312 1413 bahreinimaryam@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 1. Patients who are over 18 years old. 2. Patients with low back pain due to musculoskeletal or isolated trauma to the back who present to the emergency department. 3. Patients who have completed ethical consent form to enter the study. 18 years no limit Both 1. Patients who have contraindications for Non-steroidal anti-inflammatory drug (NSAIDs) administration including peptic ulcer, gastrointestinal bleeding, uncontrolled hypertension, renal disease, inflammatory bowel disease, hypersensitivity or allergy to NSAIDs, asthma 2. Pregnancy 3. Patients suffering from multiple trauma. Treatment - Drugs Treatment - Drugs Intervention group: Intravenous Ibuprofen Intervention group: Intravenous Ketorolac Pain reduction. Timepoint: At the entrance to the emergency department, after 10, 30 and 60 minutes. Method of measurement: Pain intensity measured by Numeric rating scale. Medication adverse effects. Timepoint: In the observation time. Method of measurement: Patient complaints of adverse effects during observation. Tehran University of Medical Sciences Approved 2018-09-06 Ethics committee of Tehran University of Medical Sciences Emergency Department, Sina Hospital, Imam-Khomeini Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)