Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342648
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-19
Brief Title:
Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Comparison Between Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic A Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department In this trial patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale VAS measured and compared
Detailed Description:
Renal colic affects over 12 of the global population at some point in their lives and recurrence rates are 50 Renal colic affects approximately 12 million people annually and is the reason for 1 of emergency department visits and hospital stays Urinary tract obstruction caused by calculi is the most common cause of renal colic occurrence The sudden onset of colicky pain that begins in the flank and radiates to the groin is the classic clinical feature of a ureteric colic Most people agree that this pain is the worst that humans have ever felt Renal colic pain can be effectively managed with a variety of pharmacologic treatments including nonsteroidal anti-inflammatory drugs NSAIDs opioid analgesics antispasmodics and antidiuretic hormones However the best analgesic regimen has not yet been identified In patients with renal colic intravenous IV injections of analgesics-either opioids or NSAIDs-remain standard clinical procedures for managing pain While there have been reports of success with IV administration of these medications side effects and availability are typically problematic particularly in private clinics or with opioid abuse Furthermore because NSAIDs may reduce renal blood flow and obstruct the kidneys autoregulatory response to obstruction preexisting renal disease may exacerbate renal failure The majority of doctors are also uncomfortable using these medications because of their side effects which include hypotension respiratory depression dizziness nausea vomiting narcotic dependence sedation and lightheadedness Therefore it would appear that using alternate treatments to manage renal colic pain is inevitable In this trial the investigators will compare the Visual Analogue Scale VAS in patients with renal colic after being managed with intracutaneous sterile water injection and intramuscular diclofenac sodium injection
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