"Management of Low Back Pain in the Emergency Department With Different Analgesic Dosages"

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The worldwide prevalence of low back pain makes it one of the most common musculoskeletal disorders, and it ranks among the primary complaints in emergency departments. Literature review 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.

The expected benefit of the research is to determine whether the analgesic effectiveness of ibuprofen 400 mg is equivalent to that of 800 mg, thereby potentially reducing the unnecessary use of higher doses of NSAIDs. Alternatively, if the 800 mg parenteral form proves to be more effective, it may suggest recommending the standard single-dose use of 800 mg for analgesia in acute mechanical low back pain.

The research is designed as a prospective, randomized-double-blind, single-center study.

The study is divided into two arms, labeled as Arm 1 and Arm 2. Randomization will be conducted by the principal investigator. For patients who agree to participate in the study, pre-assigned medications will be administered using a computer program. The relevant medications will be numbered and placed in envelopes within this computer program, which will then be labeled as Treatment 1 and Treatment 2. The randomly selected medication (Treatment 1 or Treatment 2) will be administered by a nurse, and the administering nurse will subsequently be separated from the patient's treatment and follow-up.

Upon the arrival of a patient who meets the inclusion criteria, the informed consent form will be obtained. The patient will be assigned to the research arm according to the randomization scheme. Research arms are divided into Arm 1 and Arm 2. In both arms, ibuprofen solutions of 400 mg/4 ml and 800 mg/8 ml will be prepared and administered as rapid infusions over 10 minutes in 150 ml of saline solution (0.09% NaCl).

After the patient arrives, the attending physician will inform the nurse that a patient is being enrolled in the study. The nurse will prepare the injector as specified in the order. The patient will be asked to mark their pain level on a 10-point NRS before injection. They will be asked to mark their pain level again at 15, 30, 60, and 120 minutes. If there is no relief in pain level by the 30th minute or if the pain level does not decrease to the desired level (NRS>3) at 60 or 120 minutes, rescue medication will be administered.

The rescue medication protocol will involve tramadol citrate 100 mg. It will be administered as an intravenous infusion in 500 cc of normal saline over 20-30 minutes to minimize possible side effects and ensure controlled delivery.

If the patient wishes to withdraw from the study during this follow-up period or if any complications arise, they will be withdrawn from the study. ;

Related Conditions & MeSH terms

• Analgesia
• Back Pain
• Emergencies
• Ibuprofen
• Low Back Pain
• Low Back Pain, Mechanical
• Pain Management

• NCT number: NCT06064175
• Study type: Interventional
• Source: Ankara City Hospital Bilkent
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2022
• Completion date: March 1, 2023