Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06064175
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2023-09-26
Brief Title:
Management of Low Back Pain in the Emergency Department With Different Analgesic Dosages
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 patients 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 mg4 ml and 800 mg8 ml will be prepared and administered as rapid infusions over 10 minutes in 150 ml of saline solution 009 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 NRS3 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
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 patients 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 mg4 ml and 800 mg8 ml will be prepared and administered as rapid infusions over 10 minutes in 150 ml of saline solution 009 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 NRS3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None