Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic

NCT ID: NCT06342648

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-30

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 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.

Conditions

Renal Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intracutaneous sterile water injection (ISWI)

Sterile water will be intramuscularly injected in the intracutaneous sterile water injection (ISWI) group (Group I) in a plane parallel to the posterior midline, adhering to a predetermined injection pattern from the level of the iliac crest to the last rib.

Group Type: ACTIVE_COMPARATOR

Sterile Water Injection

Intervention Type: DRUG

Injection of intracutaneous sterile water

Intramuscular diclofenac sodium injection (DIC)

Diclofenac sodium injection intramuscularly (Group II): Diclofenac sodium injection intramuscularly (75 mg) will be given to 285 patients in total.

Group Type: ACTIVE_COMPARATOR

Diclofenac Sodium injection

Intervention Type: DRUG

Injection of intramuscular diclofenac sodium

Interventions

Sterile Water Injection

Injection of intracutaneous sterile water

Intervention Type: DRUG

Diclofenac Sodium injection

Injection of intramuscular diclofenac sodium

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrhman Alshawadfy

Clinical Professor Suez Canal University Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Abdelrhman Alshawadfy, MD

Role: CONTACT

abdelrhmanalshawadfy@gmail.com

01091091620 ext. 002

Other Identifiers

Cutaneous water in renal colic

Identifier Type: -

Identifier Source: org_study_id