Renal ColicPhase 2NCT05653401
Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine.
A Phase 2 study testing Magnesium sulfate and diclofenac and Lidocain and diclofenac in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
Trial summary
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department. 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?
- Magnesium sulfate and diclofenac and Lidocain and diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Nov 2022to 1 Aug 2023
- Phase
- Phase 2
- 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
- Informed consent.
- Age between 18 and 65 years .
- Diagnosis of renal colic made by an emergency medicine physician, based on history and clinical findings, and urine analysis or by identifying the urinary tract stone using ultrasonography or radiologic imaging including CT scan .-With moderate to severe pain (visual analogic Scale ≥5 ).
Who cannot join
- known renal or hepatic dysfunction, use of NSAIDs and/or opioids within 6 h before presentation
- history of bleeding diathesis, history of peptic ulcer disease or gastrointestinal hemorrhage,
- History of cardiac arrhythmia, severe coronary artery disease, seizures, presence of any peritoneal sign, altered mental status, and anticoagulant medication or coagulation disorders.
- Use of any analgesics or spasmolytics in the previous 4 hours before admission, hemodynamic instability, and prior known allergy to lidocaine or morphine .
- Pregnant women , Breast feeding
- Allergy or contraindications to NSAIDs, lidocaine or MgSO 4
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Monastir, 5000
About this study
Official title: Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
Read the detailed description
Magnesium Sulfate (MgSO4) is a N-Methyl-D-aspartate (NMDA) receptor antagonist and is thought to be involved in the modulation of pain. There has been little direct evidence that MgSO4 relieve neuropathic pain and prevents opioid-induced hyperalgesia in humans.
Intramuscular Diclofenac seems to offer the most effective sustained analgesia for renal colic in the ED and has few side effects.
Lidocain became the agent of choice in visceral and central pain. Intravenous Lidocain is effective in the management of neuropathic pain such as diabetic neuropathy, post-surgical pain, post-herpetic pain, headaches and neurological malignancies. At low doses, Lidocain is known as a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.
Objective of study:
Evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous Lidocain combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the ED with renal colic and whether it can reduce opioid consumption.
- Conditions
- Renal Colic
- Being tested
- Magnesium sulfate and diclofenac, Lidocain and diclofenac, Placebo and diclofenac
- Keywords
- Acute pain, Renal colic, Magnesium Sulfate, Lidocain, Diclofenac
- Medical subject headings
- Renal Colic, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate and diclofenacDrug
Also called Intravenous Magnesium Sulfate combined to Diclofenac
Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 1 g of Magnesium Sulfate solution diluted in 10 ml of saline solution administered over 2 to 4 minutes
Lidocain and diclofenacDrug
Also called Intravenous Lidocain combined to Diclofenac
Intramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 10 ml of Lidocaine 1% solution administered over 2 to 4 minutes.
Placebo and diclofenacDrug
Also called Diclofenac alone with placebo ( serum saline )
Intramuscular injection of 75 mg of Diclofenac solution and 10 ml Intravenous injection of serum saline ( as a Placebo Comparator ) administered over 2 to 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Active comparator | Intravenous Magnesium Sulfate combined to Diclofenac Receives: Drug: Magnesium sulfate and diclofenac |
| Lidocaine | Active comparator | Intravenous lidocaine combined to Diclofenac Receives: Drug: Lidocain and diclofenac |
| Diclofenac | Active comparator | Intramuscular Diclofenac alone Receives: Drug: Placebo and diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
Significant pain reduction as at least a 50% drop of VAS Score of the initial pain score at 30 min after analgesia administration ( Drop VAS Score is in favour of analgesic treatment efficiency )
Measured: 30 minutes
Secondary outcomes (3)
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
Measured: 90 min
Adverse effect
nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol
Measured: 90 minutes
The need for additional analgesics at 30 minutes after protocol start to relieve the pain
The need for rescue analgesia
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Nov 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653401
- Sponsor's protocol ID
- UMonastir2022
- Status last verified
- Sep 2023
- First submitted
- 7 Dec 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Renal Colic in the Emergency Department: Comparison Between Magnesium Sulfate and Lidocaine. A Double-blind, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05653401
- Acronym / sponsor ID
- UMonastir2022
- Conditions
- Renal Colic
- Keywords
- Acute pain, Renal colic, Magnesium Sulfate, Lidocain, Diclofenac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 16 Dec 2022 (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.
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
Detailed description
Magnesium Sulfate (MgSO4) is a N-Methyl-D-aspartate (NMDA) receptor antagonist and is thought to be involved in the modulation of pain. There has been little direct evidence that MgSO4 relieve neuropathic pain and prevents opioid-induced hyperalgesia in humans.
Intramuscular Diclofenac seems to offer the most effective sustained analgesia for renal colic in the ED and has few side effects.
Lidocain became the agent of choice in visceral and central pain. Intravenous Lidocain is effective in the management of neuropathic pain such as diabetic neuropathy, post-surgical pain, post-herpetic pain, headaches and neurological malignancies. At low doses, Lidocain is known as a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.
Objective of study:
Evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous Lidocain combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the ED with renal colic and whether it can reduce opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Double blind study
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Active comparator | Drug: Magnesium sulfate and diclofenacIntravenous Magnesium Sulfate combined to Diclofenac |
| Lidocaine | Active comparator | Drug: Lidocain and diclofenacIntravenous lidocaine combined to Diclofenac |
| Diclofenac | Active comparator | Drug: Placebo and diclofenacIntramuscular Diclofenac alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent.
- Age between 18 and 65 years .
- Diagnosis of renal colic made by an emergency medicine physician, based on history and clinical findings, and urine analysis or by identifying the urinary tract stone using ultrasonography or radiologic imaging including CT scan .-With moderate to severe pain (visual analogic Scale ≥5 ).
Key exclusion criteria (6 listed)
- known renal or hepatic dysfunction, use of NSAIDs and/or opioids within 6 h before presentation
- history of bleeding diathesis, history of peptic ulcer disease or gastrointestinal hemorrhage,
- History of cardiac arrhythmia, severe coronary artery disease, seizures, presence of any peritoneal sign, altered mental status, and anticoagulant medication or coagulation disorders.
- Use of any analgesics or spasmolytics in the previous 4 hours before admission, hemodynamic instability, and prior known allergy to lidocaine or morphine .
- Pregnant women , Breast feeding
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 |
|---|---|---|
| Magnesium sulfate and diclofenacAlso: Intravenous Magnesium Sulfate combined to DiclofenacIntramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 1 g of Magnesium Sulfate solution diluted in 10 ml of saline solution administered over 2 to 4 minutes | Drug | Magnesium Sulfate |
| Lidocain and diclofenacAlso: Intravenous Lidocain combined to DiclofenacIntramuscular injection of 75 mg/ 3 ml of Diclofenac solution Intravenous injection of 10 ml of Lidocaine 1% solution administered over 2 to 4 minutes. | Drug | Lidocaine |
| Placebo and diclofenacAlso: Diclofenac alone with placebo ( serum saline )Intramuscular injection of 75 mg of Diclofenac solution and 10 ml Intravenous injection of serum saline ( as a Placebo Comparator ) administered over 2 to 4 minutes. | Drug | Diclofenac |
Primary outcome
Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration.
Time frame: 30 minutes
Significant pain reduction as at least a 50% drop of VAS Score of the initial pain score at 30 min after analgesia administration ( Drop VAS Score is in favour of analgesic treatment efficiency )
3 secondary outcomes
The proportion of participants with persistent pain (VAS > 2) at the end of the study (90 min)
Time frame: 90 min
Adverse effect
Time frame: 90 minutes
The need for additional analgesics at 30 minutes after protocol start to relieve the pain
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Semir Nouira, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium sulfate and diclofenac and Lidocain and diclofenac in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success evaluated By VAS Score ( 10 cm Visual analogue Score ) 30 minutes after drug administration. (time frame: 30 minutes). 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 21 Sep 2023.