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IRCT20200322046833N2 IRCT 2021-05-22 Tehran University of Medical Sciences Evaluation of the effectiveness of gabapentin in the control of renal colic pain Comparison of the effect of gabapentin with placebo in reducing acute pain in patients with renal colic referred to Sina Hospital emergency department 2021-05-22 anticipated 80 Complete https://irct.ir/trial/56066 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block randomization method, with block size of 8. As we have 5 blocks of 8 as follows: aaaabbbb .1 aaabbbba .2 aabbaabb .3 aabbabab .4 abababab .5 And 80 patient cases that will be divided into 10 groups of 8. Each of these groups will be randomly assigned the number one of the blocks and then we will act based on training a and b of that block for the patient. (a and b are one drug group and the other is a placebo group to which the student is blind), Blinding description: In this study, participants and students, as clinical caregivers and outcome assessors, are blind. Gabapentin capsules are placed in larger capsules and the empty space is filled with flour. Placebo capsules are similar to the capsules of the drug group, but are filled with flour. The names a and b are then randomly assigned to the capsule bag of the drug and placebo, and only the researcher will know the nature of the drug or the placebo a and b. 3 Acute renal colic pain. Intervention 1: Intervention group: Ketorolac with a dose of 30 mg and gabapentin from Mehr Daroo Pharmaceutical Company, two capsules with a dose of 300 mg and morphine with a dose of 0.05 mg per kg by titration method. Intervention 2: Control group: Ketorolac with a dose of 30 mg, placebo two capsules containing flour and morphine with a dose of 0.05 mg per kg by titration method. Yes - There is a plan to make this available What will be shared: Clinical results will be published through an original article and All other data will be available on request When: Up to 5 years after publishing the clinical results To whom: Researchers and ethics committee Conditions: Ethical evaluation and review articles without financial conflicts of interest. Where to obtain: Responsible Researcher Dr farhadnajmeddin by the following email f-najmeddin@tums.ac.ir How to obtain: Data will be available within 2 weeks after the email check. The email should include the Conflict of interest disclosure Comments:
public Farhad Najmeddin
Sina hospital pharmacy, Hassan-abad square, Tehran
Tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ +98 21 6312 1402 farhad.najm@gmail.com Tehran University of Medical Sciences scientific Farhad Najmeddin
Sina hospital pharmacy, Hassan-abad square, Tehran
Tehran Iran (Islamic Republic of) ١١٣٦٧٤٦٩١١ +98 21 6312 1402 farhad.najm@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-85 years with moderate to severe acute renal colic pain Obtaining informed written consent from the patient 18 years 85 years Both History of severe kidney failure History of moderate to severe liver failure History of allergic reactions to gabapentin or its formulation components Consumption of pregabalin and gabapentin during the last week Intolerance to food Dissatisfaction with entering the study History of unknown lung disease or history of pulmonary insufficiency in COPD or fibrosis of the lung N23 Unspecified renal colic Treatment - Drugs Placebo Intervention group: Ketorolac with a dose of 30 mg and gabapentin from Mehr Daroo Pharmaceutical Company, two capsules with a dose of 300 mg and morphine with a dose of 0.05 mg per kg by titration method Control group: Ketorolac with a dose of 30 mg, placebo two capsules containing flour and morphine with a dose of 0.05 mg per kg by titration method The average pain intensity at 4 o'clock. Timepoint: Measurement of pain intensity at the time of patient admission and then every 5 minutes after drug administration and finally 4 and 8 hours after drug administration. Method of measurement: Ask the patient how much pain using the Visual Analogue Scale method. The average amount of morphine consumed in each group. Timepoint: At the time of the patient's arrival and every 5 minutes after the drug is administered, morphine is added to the treatment as rescue if the pain is severe (pain above 7 out of 10). Method of measurement: Sum of the amount of morphine consumed from the moment of arrival until the patient is discharged. Mean pain control time. Timepoint: From the moment the patient arrives until discharge. Method of measurement: From ketorolac injection to pain control below 5, no narcotics (at least 3 hours after the last narcotics) or discharge. Tehran University of Medical Sciences Approved 2021-01-11 Ethics committee of Tehran university of medical sciences Tehran university of medical sciences, Enghelab Ave, Enghelab square, Tehran Tehran Tehran Iran (Islamic Republic of)