Comparison of the effect of gabapentin with placebo in reducing acute pain in patients with renal colic referred to Sina Hospital emergency department

Evaluation of the effectiveness of gabapentin in the control of renal colic pain Evaluation of the effectiveness of gabapentin in reducing opioid use in controlling acute renal colic pain

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients. Excel software rand function is used for refinement.

Among number of patients who referred to the emergency department of Sina Hospital in Tehran due to renal colic pain, after examining the inclusion and exclusion criteria, one group is given 30 mg of ketorolac with 600 mg of gabapentin and the other group is given 30 mg of ketorolac with placebo.(Students and caregivers are blind)The severity of pain at the time of admission and after every 5 minutes is assessed by visual analogue scale. If the pain is severe and the patient's condition is normal, 0.05mg/kg of Morphine is added to the treatment as a rescue until the patient's pain falls below 5.

Entry requirements : Patients aged 18-85 years with moderate to severe acute renal colic pain; Obtaining informed written consent from the patient Exit conditions: Patients with: 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; Unknown lung disease or history of lung failure in the field of COPD or fibrosis of the lung

We have two intervention groups. Intervention group 1: Gabapentin group (600 mg) which contains two 300 mg gabapentin capsules. Second intervention group: placebo group which contains two capsules of flour.

How long it takes to control pain, pain at discharge, and the sum of the need for drugs

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)

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.

Clinical results will be published through an original article and All other data will be available on request

Up to 5 years after publishing the clinical results

Researchers and ethics committee

Ethical evaluation and review articles without financial conflicts of interest.

Responsible Researcher Dr farhadnajmeddin by the following email f-najmeddin@tums.ac.ir

Data will be available within 2 weeks after the email check. The email should include the Conflict of interest disclosure