Clinical Trials Logo

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 570
Est. completion date December 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients between the ages of 18 and 65. - Patients with renal colic at the emergency department of the 30 June Center for Urology and Nephrology, Ismailia, Egypt. Exclusion Criteria: - Cardiovascular diseases. - Renal, and hepatic dysfunction. - Hypersensitivity to any of the used drugs. - Addiction or chronic use of opioids.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sterile Water Injection
Injection of intracutaneous sterile water
Diclofenac Sodium injection
Injection of intramuscular diclofenac sodium

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Suez Canal University

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) Comparing the Visual Analogue Scale (VAS) between patients who had intramuscular diclofenac sodium injection and intracutaneous sterile water injection for the treatment of renal colic. One of the pain rating instruments that Hayes and Patterson used for the first time was the Visual Analogue Scale (VAS), introduced in 1921. A straight line represents the visual analog scale for pain, with zero representing no pain and ten representing the worst possible pain. A patient indicates on the line the location of the point that corresponds to their level of pain. For 45 minutes, the VAS will be measured three times, at 15, 30, and 45 minutes of the procedure.
See also
  Status Clinical Trial Phase
Withdrawn NCT01685658 - Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations Phase 4
Completed NCT01349244 - Hydronephrosis on Ultrasound With CT Finding in Patients With Renal Colic N/A
Recruiting NCT04169555 - "Point of Care" Ultrasound and Renal Colic N/A
Completed NCT04160520 - Pramipexole and Morphine for Renal Colic Phase 1/Phase 2
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Completed NCT01979042 - Urinary Markers for Unilateral Kidney Obstruction N/A
Completed NCT03865004 - Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment Phase 4
Completed NCT03638921 - 35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER Phase 2
Completed NCT03706404 - Renal Colic Fast Track Pathway in the Emergency Department. N/A
Completed NCT03665753 - Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED Early Phase 1
Not yet recruiting NCT05150899 - Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm
Recruiting NCT03790514 - Heat Wrap for Renal Colic N/A
Completed NCT00646061 - Pain Control in Renal Colic Phase 1
Completed NCT05653401 - Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. Phase 2
Not yet recruiting NCT02782273 - Morphine Versus Ketorolac in Renal Colic Phase 4
Completed NCT01352676 - Limit Computed Tomography (CT) Scanning in Suspected Renal Colic
Not yet recruiting NCT06412900 - Radiomics and Image Segmentation of Urinary Stones by Artificial Intelligence
Recruiting NCT03137498 - Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department Phase 4
Recruiting NCT01742689 - Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic Phase 3
Completed NCT01546701 - Buprenorphine in Acute Renal Colic Pain Management Phase 4