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

The comparison of the efficacy and adverse effects of intravenous ketorolac and ibuprofen in the pain management of patients with acute low back pain

Two arm parallel groups triple blind including patients, researchers and the data supervision and safety committee randomised by a random computerized concealed sequence carried out at an external site (Example 3 as below) Sample size: 70 patients in total for 2 groups

This is a triple blind study. 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. The study will be implemented in the emergency department of Sina, Imam-Khomeini and Shariati hospitals in Tehran.

Participants are patients with acute low back pain (LBP) that did not report their pain for more than 3 months due to musculoskeletal or isolated trauma to the back. Furthermore, patients with increasing low back pain will be included in this study. Inclusion criteria: 1. Patients over 18 years-old 2. Patients with the complaint of musculoskeletal or isolated traumatic LBP 3. Patients having consented to enter the study Exclusion criteria: 1. Patients who have contraindications for Non-steroidal anti-inflammatory drugs (NSAIDs) 2. Pregnancy 3. Multiple trauma patients

Group 1: 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. Group 2: Intravenous Ketorolac: The administration of 30 mg Ketorolac in 2 cc syringe in 30 seconds and then, 500 cc normal saline in 30 minutes

Pain score; Adverse effects

Intravenous Ibuprofen was unavailable at times during the study. We recruited the rest of the samples when they were again available. Therefore, we updated the study end date.

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.

This is a triple blind study (patient, researcher, the data and safety monitoring board, 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

All data can be exposed anonymously.

In the review process of the article

Data will be only accessible for the researchers in the educational institutes.

If the reviewers of journals request for the data, it will be sent for them anonymously.

People can reach the data via an email request by declaring their rationale.

People can reach the data via an email request by declaring their rationale. Data will be accessible in approximately 1 week by the researchers or reviewers.