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IRCT20201003048903N1 IRCT 2020-10-21 Jahrom University of Medical Sciences The effect of pethidine, ketrolac and the combination of ketorolac and diazepam on low back pain Comparison between the effect of pethidine, ketorolac and ketorolac-diazepam combination in reducing pain in patients with acute low back pain referred to the emergency department 2019-10-25 anticipated 90 Complete https://irct.ir/trial/51383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our study, patients were divided into 3 equal groups by block randomization. The randomization method was that for each group, 15 numbers in one envelope for men and 15 numbers in other envelopes for women were sampled by the nurse in charge (a total of 30 envelopes for each group). The nurse in charge of sampling for randomly referred patients once removed a number from a group of men and once a bag of women, respectively, and delivered it to the patient, to be delivered to the doctor by the time of referral. For the next group, the same thing was done consecutively with the first group, and for the third group, the same thing was repeated. The nurse wrote down in a notebook which group the person referred to the doctor belonged to and wrote it down. But neither the doctor nor the patient himself knew in which study group the patient was placed, Blinding description: In this study, physicians and nurses in the emergency department of Peymaniyeh Hospital, as well as those responsible for data collection, were blinded like patients. 3 low back pain. Intervention 1: Intervention group: The first group consisted of 30 patients with low back pain who received 50 mg of pethidine (intravenously). Intervention 2: Intervention group: The second group consisted of 30 patients with low back pain who received 30 mg of ketorolac (ampoule) and 10 mg of diazepam intravenously. Intervention 3: Intervention group: The third group consisted of 30 patients with low back pain who received 30 mg of ketrolac alone (ampoule) intravenously. Yes - There is a plan to make this available What will be shared: Patients 'personal data, including patients' first and last names, will not be disclosed in accordance with ethical obligations. Data on the main outcomes of the study will be published. When: The access period starts 6 months after the results are published To whom: Post-publication study data is available to all researchers. Conditions: The data can be used with the permission of the researcher and therapeutic uses. Where to obtain: Research Council of Jahrom University of Medical Sciences How to obtain: Request for access to the data of the present study must be submitted in writing to the Committee and Research Council of Jahrom University of Medical Sciences and with ethical commitments. Comments:
public Esmaeal Rayat Dost
Motehari street
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5433 6085 e.rayat.dost@gmail.com Jahrom University of Medical Sciences scientific Esmaeal Rayat Dost
Motehari street
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5433 6085 e.rayat.dost@gmail.com Jahrom University of Medical Sciences Iran (Islamic Republic of) All patients who refer to the emergency department of Peymanieh Hospital in Jahrom due to acute low back pain in 2019-2020. Informed consent to attend the study 18 years 80 years Both G89.29 Other chronic pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first group consisted of 30 patients with low back pain who received 50 mg of pethidine (intravenously). Intervention group: The second group consisted of 30 patients with low back pain who received 30 mg of ketorolac (ampoule) and 10 mg of diazepam intravenously. Intervention group: The third group consisted of 30 patients with low back pain who received 30 mg of ketrolac alone (ampoule) intravenously. Pain. Timepoint: In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' pain was measured in the time periods before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection. Method of measurement: Pain variable was measured in this study using Visual Analogue Scale. Blood pressure. Timepoint: In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' blood pressure was measured in the time periods before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection. Method of measurement: In this study, blood pressure was measured using a manual blood pressure monitor and a cuff monitoring device. Heart rate per minute. Timepoint: In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' heart rate was measured at the time before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection. Method of measurement: The heart rate of patients in this study was measured by a nurse in the emergency department and a monitor installed in the emergency department. The amount of oxygen saturation in the blood. Timepoint: In this study, the effect of pethidine, ketrolac and ketrolac-diazepam combination on patients' blood oxygen saturation was measured at the time before injection, immediately after injection, 5, 10, 20, 60 and 90 minutes after injection. . Method of measurement: Patients' blood oxygen levels were measured using a monitor installed in the emergency department. Jahrom University of Medical Sciences Approved 2019-01-30 Ethics Committee of Jahrom University of Medical Sciences Jahrom University of Medical Sciences Campus Building ,Ostad Motahhari Blvd, after the School of Nursing and Midwifery, Jahrom City, Iran Jahrom Fars Iran (Islamic Republic of)