A Phase 2 interventional study of Magnesium sulfate and diclofenac and Lidocain and diclofenac in Renal Colic, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by University of Monastir · Phase 2, Interventional, and Treatment
Among 10 studies in Renal Colic by University of Monastir — 3 open to participants now, 3 under way, 1 of them phase 3. Renal Colic · University of Monastir.
Among the 10 studies in Renal Colic by University of Monastir, this one is one of 2 that started in 2022, is one of 4 in phase 2, and was the 6th registered.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's enrollment of 800 is above the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →3 of the 10 studies in Renal Colic by University of Monastir are open now, in 1 country. Each count lists the studies.
Of the 5 Renal Colic studies recruiting now, 2 (40%) set no upper age limit and 2 (40%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2022.
Median enrollment 500 across the 9 interventional studies, 878 across the 1 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
1 of the studies in Renal Colic by University of Monastir that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05722782University of MonastirOral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics | 2027-06 |
Among the 10 studies in Renal Colic by University of Monastir, from their registry updates:
Rate of Intravenous Magnesium Sulfate Vs Lidocaine to treat Renal Colic in the Emergency Department.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous Magnesium Sulfate combined to Diclofenac
Drug: Magnesium sulfate and diclofenac
Intravenous lidocaine combined to Diclofenac
Drug: Lidocain and diclofenac
Intramuscular Diclofenac alone
Drug: Placebo and diclofenac
Drug pages: Magnesium Sulfate · 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
Also known as: Intravenous Magnesium Sulfate 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.
Also known as: Intravenous Lidocain combined to Diclofenac
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.
Also known as: Diclofenac alone with placebo ( serum saline )
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 )
Time frame: 30 minutes
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)
Time frame: 90 min
Adverse effect
nausea, vomiting, vertigo, and lethargy based on self-reports and other clinical manifestations occuring at any moment of the protocol
Time frame: 90 minutes
The need for additional analgesics at 30 minutes after protocol start to relieve the pain
The need for rescue analgesia
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Aug 2023, 8 months.
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Studies of the drugs tested here: Magnesium Sulfate · Diclofenac