Comparison of the effectiveness of two intravenous doses of ketorolac for the treatment of acute renal colic in patients referred to the emergency department

This study designed to compare the effect of two doses of 15 and 30 mg of Ketorolac in the treatment of acute pain in patients referred to renal colic in the emergency department of Khatam-al-Anbia Hospital in Zahedan

A randomized clinical trial with parallel, double-blind,phase2, on 160 patients, block randomization

Patients referred to the emergency room of Khatam-al-abia Hospital in Zahedan who will be treated for renal colic based on clinical findings admitted.The diagnosis of renal colic is based on CT-scan without abdominal contrast. Patients are randomly divided into two groups receiving15or 30mg ketorolak(prepared in 5cc syringes with the same appearance) at the beginning of hospitalization. Participants and research evaluator isn't aware of the drug group. In cases where pain control isn't achieved with ketorolac injection, the intravenous morphine rescue dose of 0.1mg/kg will be used as an alternative and the number of morphine rescue doses will be recorded. Vital signs and VAS will be assessed at the time of admission (before drug injection), 20, 40 and 60 minutes after injection.

Patients older than 16 years old with moderate to severe acute renal colic are included. Patients older than 70 years of age; pregnant or lactating; with gastrointestinal problems such as gastritis, peptic ulcer or acute bleeding; hypersensitivity to nonsteroidal anti-inflammatory drugs; unstable vital signs ,and patients using analgesia medications are excluded.

Patients in both groups are treated with15 mg or 30 mg ketorolac. The effectiveness of the two doses of this drug and its side effects are evaluated , and if there is no response to treatment, the next treatment is the use of morphine.

Reduction of numerical pain scale; vital signs; side effects; the need for life-saving pain relief; patient satisfaction

Samples are randomly divided into two groups of 8 blocks. Thus, according to the order of patient placement in the group of 8 in each block, 4 patients from group A and 4 patients from group B will be randomly placed. Then, when referring, a block is selected, and based on the patient's entry order and the card row in each block, the patient will be assigned to the relevant group.

The drug groups will be prepared in doses of 15 mg (group A) and 30 mg (group B) in 5cc syringes with the same appearance. At the beginning of the hospitalization, patients are randomly divided into two groups receiving ketorolac (15 or 30 mg ketorolac). In one group, ketorolac at a dose of 15 mg (group A) is administered intravenously and in the other group, ketorolac at a dose of 30 mg (group B) is used intravenously. The classification of patients and the type of medication used for the people involved in the study are blinded and the researcher evaluating the patients is not aware of the drug group prescribed to patients during the study. For this purpose, all syringes of both groups have the same appearance and volume with the same frequency of use in both groups. Other common treatments also apply to both groups. Therefore, the study will be conducted in a double-blind manner.

All data is potentially shareable after unidentified individuals

Access period starts 5 months after the results are published

The data from this study will be available to academic and scientific researchers as well as people working in industry (if needed)

The data from the present study will be usable for other researchers, provided the source and citation are preserved.

Applicants can send their application through the mailing address sheida.mehrdad@zaums.ac.ir Dr. Sheida Mehrdad.

After sending a request to receive the documents to Dr. Sheida Mehrdad, he will check the identity of the applicant and the type of application and will send the documents in less than two weeks