Treatment of Renal Colic in the Emergency Departement (ED).
מילות מפתח
תַקצִיר
תיאור
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.
תאריכים
| אומת לאחרונה: | 05/31/2017 |
| הוגש לראשונה: | 05/13/2017 |
| ההרשמה המשוערת הוגשה: | 06/23/2017 |
| פורסם לראשונה: | 06/26/2017 |
| העדכון האחרון הוגש: | 06/23/2017 |
| עדכון אחרון פורסם: | 06/26/2017 |
| תאריך תחילת לימוד בפועל: | 06/30/2016 |
| תאריך סיום משוער משוער: | 12/31/2017 |
| תאריך סיום משוער ללימודים: | 11/30/2018 |
מצב או מחלה
התערבות / טיפול
Drug: Diclofenac
Drug: Intravenous Magnesium sulfate combined to Diclofenac
Drug: intravenous lidocaine combined to diclofenac
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Active Comparator: Intravenous Magnesium sulfate combined to Diclofenac | Drug: Intravenous Magnesium sulfate combined to Diclofenac intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes |
| Active Comparator: intravenous lidocaine combined to diclofenac | Drug: intravenous lidocaine combined to diclofenac intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes |
| Active Comparator: diclofenac alone |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 18 Years ל 18 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | Inclusion Criteria: - Informed consent. - Age > 18years. - Confirmed renal colic - With moderate to severe pain (visual analogic Scale ≥4). Exclusion Criteria: - 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 - Contraindication to one of the protocol treatment - Inability of the patient to cooperate - Allergy to NSAID or lidocaine. |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Treatment success evaluated at 30 minutes after drug administration. [30 minutes]
2. Pain resolution time evaluated at 5, 10, 30, 60 and 90 minutes after drug administration. [90 minutes]
אמצעי תוצאה משניים
1. The proportion of patients achieving a drop in initial pain score of at least 3 evaluated at 30 minutes [30 minutes]
2. Adverse effect [90 minutes]
3. The need for additionnal analgesics at 30 minutes after protocol start to releive the pain [30 minutes]
