Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic

March 28, 2024 updated by: Abdelrhman Alshawadfy, Suez Canal University

Comparison Between Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
570

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Sterile Water Injection
Injection of intracutaneous sterile water
Active Comparator: 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.
Drug: Diclofenac Sodium injection
Injection of intramuscular diclofenac sodium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: For 45 minutes, the VAS will be measured three times, at 15, 30, and 45 minutes of the procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cutaneous water in renal colic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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