Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic

NCT06342648 | Not Yet Recruiting

• 1 other identifier: Cutaneous water in renal colic
• Study Type: interventional
• Target: 570
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intracutaneous sterile water injection (ISWI)

ACTIVE COMPARATOR

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.

Drug: Sterile Water Injection

Intramuscular diclofenac sodium injection (DIC)

ACTIVE COMPARATOR

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

Drug: Diclofenac Sodium injection

Interventions

Sterile Water Injection DRUG

Injection of intracutaneous sterile water

Intracutaneous sterile water injection (ISWI)

Diclofenac Sodium injection DRUG

Injection of intramuscular diclofenac sodium

Intramuscular diclofenac sodium injection (DIC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cardiovascular diseases.
• Renal, and hepatic dysfunction.
• Hypersensitivity to any of the used drugs.
• Addiction or chronic use of opioids.

Sponsors & Collaborators

• Suez Canal University: lead

MeSH Terms

Conditions

Renal Colic

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Abdelrhman Alshawadfy, MD

CONTACT

01091091620; abdelrhmanalshawadfy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Suez Canal University Faculty of Medicine

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: May 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03