Investigating the effect of prescribing midazolam and ketorolac in comparison with prescribing morphine and ketorolac on the pain relief of renal colic patients referred to the emergency department of Khatam al-Anbia in Zahedan in 2025

Comparison of the effect of administration of midazolam and ketorolac compared to administration of morphine and ketorolac on pain relief in renal colic patients referred to the emergency room

A two-group, parallel-group, triple-blind, randomized, phase 3 clinical trial on 200 patients. The rand function of Excel software will be used for randomization.

The emergency department of Khatam Al-Anbia Hospital, Zahedan, will be the location of the research; After the patient enters the study, the patient's level of sedation will be evaluated by Ramsey's criteria, and two sets of drugs will be prescribed for patients in groups A and B. Pain scores, sedation, hemodynamic parameters, and side effects in the next 20, 40, 60, and 90 minutes. They will be registered from the intervention. The study is three-way blind.

Inclusion: 1- Men or women will be 15 to 75 years old, who will be diagnosed with acute renal colic. 2- They will get a score of 4 or higher on the visual analog scale (VAS). 3-stable in terms of hemodynamics (based on initial triage) 4- Consent of patients or patients' companions to enter the study Exclusion: 1- Allergy to morphine, ketorolac or midazolam 2- Intravenous analgesic consumption in the past 4 hours 3- Drug addiction 4- Pregnancy and breastfeeding

The first group will receive 30 mg of intravenous ketorolac within one minute and 5 mg of intravenous morphine (in a volume of 5 cc) within five minutes, and the second group will receive 30 mg of intravenous ketorolac within one minute and 2 mg of intravenous midazolam.

Renal colic pain; Level of sedation; Percentage of oxygen saturation; Breathing rate

Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age (15-30, 31-45, 46-60 and 75-61) in the order of entry. Then, they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all possible states of permutations. These blocks were created using statistical software R version 4.0.2.

In order to establish randomization and comply with the conditions of blinding, two combination packages of Ketorolac-morphine and Ketorolac-midazolam drugs are brought to the same volume and the surface of the syringes are covered and coded with A-B and C-D labels and placed in 200 numbered envelopes. and provided to the researcher.He also opens the envelopes according to the patient's choice and administers the desired prescription. In this way, the interventions were carried out in completely randomized conditions and the researcher will not know the type of intervention in each group. Also, the patient does not know the type of medicine received. At the end, the statistician will perform the necessary analysis without knowing the type of intervention in each group, and finally the name of each group will be announced by the nurse who prepares the medicine packages.

All data can be shared after de-identifying individuals.

Access starts one year after results are published

Researchers working in academic and scientific institutions

The use of documents for research exploitations in the field of drug therapy is unimpeded only for researchers.

Correspondence with the email address ali.abdolrazaghnejad@zaumas.ac.ir.

After sending the applicant's application and receiving the email, if the applicant is eligible, the data files will be sent to the email address.