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| ID | Type | Description | Link |
|---|---|---|---|
| Hamad Medical Corporation-MRC | Other Grant/Funding Number | IRGC-01-NI-045 |
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Abdominal pain is one of the most common presentations to an emergency department (ED). Among patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and to be pain free as early as possible. There are variations in physician preference to choose initial analgesic drug for managing such pain. Commonly used drugs are:
A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking. This study is design to obtain data on efficacy of these three drugs within 30 minutes in a non inferiority trail.
This will be a double blind RCT, where participants will be enrolled consecutively after meeting eligibility criteria and obtaining a written informed consent. They will be assign to one of the three study arms by computer generated randomization process. The study packets will be prepared by a dedicated nurse or pharmacist who will not a part of investigating team. Each Patients will receive one analgesic drug (active drug) and two placebos. Drugs will be given as one intramuscular injection and two intravenous solutions.
Pain score will be recorded using NRS at 0, 30, 60, and 90 minutes. Data will be collected on standard Data collection form. Each participant will receive analgesia from study packet which contains, one active drug and two placebos to be administer as one intramuscular and two intravenous solutions. At any given time every patient will receive one analgesia from either Diclofenac, Paracetamol or Morphine. If patient pain does not respond to initial treatments, at 30 minutes a rescue analgesia in form of morphine will be administered till patient is pain free or NRS<=2 or adverse event to morphine.
Based on the results of previous studies (1-3), proportion of patients achieving more than 50% pain reduction, is between 65-75% for diclofenac, morphine and paracetamol when compared with other drugs. In each group, 437 patients are required to detect a difference of 10% in primary outcome, in a superiority trial with power (1-beta) of 90% and significance level (alpha) of 5% in this study. Considering 15% extra, total sample size required in this superiority trial will be 1507 patients in total.
Data will be collected on a standard data recording form and it will be converted to electronic excel sheet hiding patient identifiable details. Continuous variables will be presented as mean with standard deviation (SD). Categorical variables will be calculated as proportions and presented with 95% Confidence interval (CI). Statistical analyses will be undertaken using Stata 12.0 (College Station, Texas).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac and Placebos | Experimental | Participants in this group will receive a Diclofenac 75 mg intramuscular injection, and two placebo saline solutions intravenously. |
|
| Morphine and Placebos | Active Comparator | Participants in this group will receive Morphine 0.1 mg/kg intravenously, along with an additional intravenous placebo and an intramuscular placebo injection. |
|
| Paracetamol and Placebos | Active Comparator | participants in this group will receive intravenous Paracetamol 1 gm solution, along with an additional intravenous placebo and an intramuscular placebo injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving a reduction of >50% on Numerical Rating Scale (NRS-11) from the initial NRS recorded at the end of 30 minutes in each study arm. | at 30 minutes after analgesia |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in mean NRS | at 30, 60 and 90 minutes after analgesia |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event rate | Within 14 days of ED visit | |
| total analgesia requirement to get pain score (NRS) less than or equal to 2. | by 90 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Sameer A. Pathan, MBBS, MCEM | Hamad Medical Corporation | Principal Investigator |
| Prof. Peter A Cameron, MD,FACEM | Hamad Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, Hamad General Hospital. | Doha | Baladiyat ad Dawhah | 3050 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20934829 | Background | Grissa MH, Claessens YE, Bouida W, Boubaker H, Boudhib L, Kerkeni W, Boukef R, Nouira S. Paracetamol vs piroxicam to relieve pain in renal colic. Results of a randomized controlled trial. Am J Emerg Med. 2011 Feb;29(2):203-6. doi: 10.1016/j.ajem.2009.09.019. Epub 2010 Oct 8. | |
| 24350118 | Background | Behzadnia MJ, Javadzadeh HR, Saboori F. Time of admission, gender and age: challenging factors in emergency renal colic - a preliminary study. Trauma Mon. 2012 Fall;17(3):329-32. doi: 10.5812/traumamon.6800. Epub 2012 Oct 10. |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D014545 | Urinary Calculi |
| D014514 | Ureteral Calculi |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D009020 | Morphine |
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Morphine |
| Drug |
|
|
| Paracetamol | Drug |
|
|
| Placebos | Drug |
|
|
| Background | Shaden Salameh; Nurit Hiller; Meir Antopolsky; Fedaa Ghanem; Yigaal Abramovitz; Ruth Stalnikowics. Diclofenac versus Tramadol in the Treatment of Renal Colic: A Prospective, Randomized Trial. The Open Emergency Medicine Journal. 2011; 4: 9-13. |
| 26993881 | Derived | Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16. |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |