Renal ColicNCT06342648
Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic
A study testing Sterile Water Injection and Diclofenac Sodium injection in people with Renal Colic, run by Suez Canal University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Sterile Water Injection and Diclofenac Sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cardiovascular diseases.
- Renal, and hepatic dysfunction.
- Hypersensitivity to any of the used drugs.
- Addiction or chronic use of opioids.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Sterile Water Injection, Diclofenac Sodium injection
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Water InjectionDrug
Injection of intracutaneous sterile water
Diclofenac Sodium injectionDrug
Injection of intramuscular diclofenac sodium
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Diclofenac Sodium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 45 minutes, the VAS will be measured three times, at 15, 30, and 45 minutes of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342648
- Sponsor's protocol ID
- Cutaneous water in renal colic
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06342648
- Acronym / sponsor ID
- Cutaneous water in renal colic
- Conditions
- Renal Colic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracutaneous sterile water injection (ISWI) | Active comparator | Drug: Sterile Water InjectionSterile 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. |
| Intramuscular diclofenac sodium injection (DIC) | Active comparator | Drug: Diclofenac Sodium injectionDiclofenac sodium injection intramuscularly (Group II): Diclofenac sodium injection intramuscularly (75 mg) will be given to 285 patients in total. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Cardiovascular diseases.
- Renal, and hepatic dysfunction.
- Hypersensitivity to any of the used drugs.
- Addiction or chronic use of opioids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile Water InjectionInjection of intracutaneous sterile water | Drug | Intracutaneous sterile water injection (ISWI) |
| Diclofenac Sodium injectionInjection of intramuscular diclofenac sodium | Drug | Intramuscular diclofenac sodium injection (DIC) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Water Injection and Diclofenac Sodium injection in people with Renal Colic, run by Suez Canal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrhman Alshawadfy, MD (01091091620 ext. 002, abdelrhmanalshawadfy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.