Renal ColicPhase 2NCT03199924
Treatment of Renal Colic in the Emergency Departement (ED).
A Phase 2 study testing Diclofenac, Magnesium Sulfate and Lidocaine in people with Renal Colic, run by University of Monastir at 1 site in Tunisia.
Trial summary
to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic
- What is being tested?
- Diclofenac, Magnesium Sulfate and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jul 2016to 31 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Age > 18years.
- Confirmed renal colic
- With moderate to severe pain (visual analogic Scale ≥4).
Who cannot join
- Current regular use of analgesics, anticonvulsants, or antidepressants.
- Analgesia taken within 24 hours .
- Renal disorder with a low glomerular filtration rate (< 60ml/min)
- Neuromuscular disorder.
- Severe cardiac disease.
- Pregnant women
Show all 9Show fewer
- Contraindication to one of the protocol treatment
- Inability of the patient to cooperate
- Allergy to NSAID or lidocaine.
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: Intravenous Magnesium Sulfate Combined to Diclofenac Versus Intravenous Lidocaine Combined to Diclofenac Versus Diclofenac Alone in the ED Treatment of Renal Colic. A Randomized Double Blind Study.
to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid consumption.
Read the detailed description
Magnesium (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 a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.
Objective of study :
The aim of this study is to 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 emergency department with renal colic and whether it can reduce opioid consumption.
- Conditions
- Renal Colic
- Being tested
- Diclofenac, Magnesium Sulfate, Lidocaine
- Keywords
- acute pain, Renal colic, Diclofenac, Lidocain, Magnesium sulfate
- 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.
DiclofenacDrug
Also called Non Steroidal Anti Inflammatories, Voltaren
Intramuscular injection of 75mg / 3ml of Diclofenac solution
Magnesium SulfateDrug
Also called MgSO4, Sulfamag
intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
LidocaineDrug
Also called lignocaine, Xylocaine
intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Magnesium sulfate combined to Diclofenac | Active comparator | Intravenous Magnesium sulfate combined to Diclofenac Receives: Drug: Diclofenac; Drug: Magnesium Sulfate |
| intravenous lidocaine combined to diclofenac | Active comparator | intravenous lidocaine combined to diclofenac Receives: Drug: Diclofenac; Drug: Lidocaine |
| diclofenac alone | Active comparator | diclofenac alone Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success evaluated at 30 minutes after drug administration.
we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration.
Measured: 30 minutes
Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration.
elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.
Measured: 90 minutes
Secondary outcomes (3)
The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes
The proportion of patients achieving a drop in initial pain score of at least 3
Measured: 30 minutes
Adverse effect
eg 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 posted27 Jun 2017
- Study start1 Jul 2016
- Primary completion1 Jan 2022
- Study completion31 Jul 2022
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
- 600 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
- Nouira semir, professor, Principal investigator, university of ùmonastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199924
- Sponsor's protocol ID
- COL-NEPHR
- Status last verified
- Aug 2022
- First submitted
- 14 May 2017
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Magnesium Sulfate Combined to Diclofenac Versus Intravenous Lidocaine Combined to Diclofenac Versus Diclofenac Alone in the ED Treatment of Renal Colic. A Randomized Double Blind Study.
- ClinicalTrials.gov ID
- NCT03199924
- Acronym / sponsor ID
- COL-NEPHR
- Conditions
- Renal Colic
- Keywords
- acute pain, Renal colic, Diclofenac, Lidocain, Magnesium sulfate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 27 Jun 2017 (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.
to evaluate the analgesic effect of a standard dose of intravenous magnesium added to intramuscular diclofenac compared to intravenous lidocaine combined to intramuscular diclofenac or intramuscular diclofenac alone in patients presenting to the emergency department with renal colic and whether it can reduce opioid consumption.
Detailed description
Magnesium (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 a relatively safe medication. Lidocain seems an effective treatment who can be administrated in the renal colic.
Objective of study :
The aim of this study is to 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 emergency department 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 |
|---|---|---|
| Intravenous Magnesium sulfate combined to Diclofenac | Active comparator | Drug: Diclofenac, Drug: Magnesium SulfateIntravenous Magnesium sulfate combined to Diclofenac |
| intravenous lidocaine combined to diclofenac | Active comparator | Drug: Diclofenac, Drug: Lidocaineintravenous lidocaine combined to diclofenac |
| diclofenac alone | Active comparator | Drug: Diclofenacdiclofenac alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent.
- Age > 18years.
- Confirmed renal colic
- With moderate to severe pain (visual analogic Scale ≥4).
Key exclusion criteria (9 listed)
- Current regular use of analgesics, anticonvulsants, or antidepressants.
- Analgesia taken within 24 hours .
- Renal disorder with a low glomerular filtration rate (< 60ml/min)
- Neuromuscular disorder.
- Severe cardiac disease.
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 |
|---|---|---|
| DiclofenacAlso: Non Steroidal Anti Inflammatories, VoltarenIntramuscular injection of 75mg / 3ml of Diclofenac solution | Drug | Intravenous Magnesium sulfate combined to Diclofenac, diclofenac alone, intravenous lidocaine combined to diclofenac |
| Magnesium SulfateAlso: MgSO4, Sulfamagintravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes | Drug | Intravenous Magnesium sulfate combined to Diclofenac |
| LidocaineAlso: lignocaine, Xylocaineintravenous injection of 10ml lidocaine 1% solution administered over 2 minutes | Drug | intravenous lidocaine combined to diclofenac |
Primary outcome
Treatment success evaluated at 30 minutes after drug administration.
Time frame: 30 minutes
we consider significant pain reduction as a drop in the initial pain score of 50% or more at 30 minutes following analgesia administration.
Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration.
Time frame: 90 minutes
elapsed time between the start of the protocol and the decrease of baseline pain score by at least 50%.
3 secondary outcomes
The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes
Time frame: 30 minutes
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 10 Aug 2022.
- 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.
Nouira semir, professor principal investigator
university of ùmonastir
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 Diclofenac, Magnesium Sulfate and Lidocaine 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 4 inclusion and 9 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 10 Aug 2022. 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 at 30 minutes after drug administration. (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 10 Aug 2022.