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IRCT20150213021063N5 IRCT 2019-01-15 Tehran University of Medical Sciences Comparison of intravenous ibuprofen and intravenous ketorolac in renal colic pain reduction Comparison of intravenous ibuprofen and intravenous ketorolac in renal colic pain reduction in the emergency department 2018-10-23 anticipated 195 Complete https://irct.ir/trial/35583 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: If a patient's pain intensity is equal or greater than 7 out of 10 after 30 minutes of drug administration, 5 milligrams intravenous morphine sulfate will be administered to the patients slowly in 5 minutes, Randomization description: Patients will be assigned to groups K, I, or M based on the random table which has been developed using hhtp://randome.org website, Blinding description: Placebo will be used in each of the groups for blinding. Drug administration will be done by someone who has no role in data collection. Patients, data collector and statistical analyst will be blinded to the prescribed drug. 3 Unspecified renal colic. Intervention 1: The first intervention group (group I): 5 mg intravenous morphine sulfate in 5 minutes + 800 mg intravenous ibuprofen in 200 milliliters normal saline in 30 minutes + 2 milliliters intravenous distilled water in 30 seconds. Intervention 2: The second intervention group (group K): 5 mg intravenous morphine sulfate in 5 minutes + 200 milliliters intravenous normal saline in 30 minutes + 30 mg intravenous ketorolac (equals to 2 milliliters) distilled water in 30 seconds. Intervention 3: Control group (group M): 5 mg intravenous morphine sulfate in 5 minutes + 200 milliliters intravenous normal saline in 30 minutes + 2 milliliters intravenous distilled water in 30 seconds. Yes - There is a plan to make this available What will be shared: All unidentified IPD and statistical analyses are sharable. When: Sُtarting 1 months after publication To whom: Data will be available for academic, scientific, or industrial institutes researchers. Conditions: Data will be shared upon Written request of the individual researcher or the institute. Where to obtain: Data will be shared by sending email to Arash Safaie. Email: a-safaie@sina.tums.ac.ir How to obtain: Data will be shared by sending email to Arash Safaie. We will try our best to send you the requested data as soon as possible. Comments:
public Arash Safaie
Emergency Department, Sina Hospital, Hassan Abad square.
Tehran Iran (Islamic Republic of) 1136746911 +98 216312413 a-safaie@sina.tums.ac.ir Tehran University of Medical Sciences scientific Arash Safaie
Emergency Department, Sina Hospital, Hassan Abad square.
Tehran Iran (Islamic Republic of) 1136746911 +98 216312413 a-safaie@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with renal colic who present to the emergency department and their pain intensities are equal or greater than 7 out of 10 18 years 65 years Both History of an allergic reaction to ASA or other NSAIDs (including asthma, skin reactions, anaphylaxis, or ...) Known chronic kidney disease Age below 18 or above 65 years Weight below 50 kilograms Peptic ulcer disease history Gastrointestinal bleeding history Suspected volume deficit (based on mucous membranes) Any active bleeding Bleeding diathesis Using anticoagulant or antiplatelet drugs Known heart failure Pregnancy Lactation Systolic blood pressure lower than 100 mmHg N23 Unspecified renal colic Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group (group I): 5 mg intravenous morphine sulfate in 5 minutes + 800 mg intravenous ibuprofen in 200 milliliters normal saline in 30 minutes + 2 milliliters intravenous distilled water in 30 seconds The second intervention group (group K): 5 mg intravenous morphine sulfate in 5 minutes + 200 milliliters intravenous normal saline in 30 minutes + 30 mg intravenous ketorolac (equals to 2 milliliters) distilled water in 30 seconds Control group (group M): 5 mg intravenous morphine sulfate in 5 minutes + 200 milliliters intravenous normal saline in 30 minutes + 2 milliliters intravenous distilled water in 30 seconds Pain intensity. Timepoint: Before drug administration, 30, 60, and 120 minutes after drug administration. Method of measurement: Numeric rating scale. Adverse events. Timepoint: Patients will be monitored continuously for adverse events since drug administration till patient discharge. Method of measurement: Specific occurred adverse event. Patient's length of stay. Timepoint: At the time of patient discharge. Method of measurement: Minutes. Tehran University of Medical Sciences Approved 2017-08-06 Tehran University of Medical Sciences medicine faculty ethics committee Building No 1- Northern gate of the university- Poursina street- Qods street- Enghelab avenue. Tehran Tehran Iran (Islamic Republic of)