Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06342648 |
Other study ID # |
Cutaneous water in renal colic |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2024 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
March 2024 |
Source |
Suez Canal University |
Contact |
Abdelrhman Alshawadfy, MD |
Phone |
01091091620 |
Email |
abdelrhmanalshawadfy[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 1.2 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
kidney's 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.