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IRCT20230425057992N1 IRCT 2023-05-16 Islamic Azad University Comparison of the effectiveness of ketorolac and diclofenac on reducing pain after surgery Comparison of the effectiveness of two combined drug regimens of venous ketorolac and diclofenac suppository in comparison with venous ketorolac alone on reducing pain after abdominal surgery under general anesthesia 2022-12-22 anticipated 44 Complete https://irct.ir/trial/69947 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study requires 44 patients to be divided into two groups and 22 patients will be placed in each group. For this purpose, the table of random numbers has been used as follows: In the table of random numbers, a number is chosen randomly with the eyes closed and by shaking the tip of the pen. Then this number is the starting point, and from this number numbers are recorded from the bottom to the top and assigned to different groups. It should be noted that the selected numbers must be two digits and smaller equal to 44.Then the first 22 numbers that were selected are assigned to group A and the next 22 numbers to group B. On the other hand, the patients undergoing surgery are numbered from 1 to 44 from the beginning of the sampling process, and according to the numbers assigned to them, they are in the subgroup A and B are placed. For group A, intravenous ketorolac drug regimen is used along with diclofenac suppositories, and for group B, intravenous ketorolac drug regimen is used alone, Blinding description: The meaning of double-blind is that neither the surgeon nor the patients will know about the randomization method and treatment protocol taken into consideration. 2 Pain reduction after abdominal surgery with general anesthesia. Intervention 1: intervention group: In this double-blind randomized clinical trial study, patients undergoing elective abdominal surgery with general anesthesia who are in anesthesia class 1 and 2 were interviewed before surgery and background information including gender, age, clinical and medication records were obtained from them. The question is recorded in the study checklist. After complete preparation, placement of intravenous line, monitoring and receiving oxygen for 3 to 5 minutes with premedication of midazolam 2 mg and fentanyl 2 cc and sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg under anesthesia induction. They are placed and then anesthesia is administered with N2O gas and isoflurane oxygen and repetition of fentanyl and atracurium. At the end of the operation and randomly using a random table of numbers, the patients are evaluated in two groups. The first group receives diclofenac suppositories (100 mg each) and Ketorolac ampoules (15 mg) in the form of infusion. Patients will not know about the randomization method and the considered treatment protocol. Pain intensity is measured during the first 6 hours of recovery and the first 12 hours after the operation. In the group with moderate and severe pain, 10 and 20 mg of pethidine is injected, and the consumption of the two groups is compared. Intervention 2: intervention group: In this double-blind randomized clinical trial study, patients undergoing elective abdominal surgery with general anesthesia who are in anesthesia class 1 and 2 were interviewed before surgery and background information including gender, age, clinical and medication records were obtained from them. The question is recorded in the study checklist. After complete preparation, placement of intravenous line, monitoring and receiving oxygen for 3 to 5 minutes with premedication of midazolam 2 mg and fentanyl 2 cc and sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg under anesthesia induction. They are placed and then anesthesia is administered with N2O gas and isoflurane oxygen and repetition of fentanyl and atracurium.At the end of the operation and randomly using a random table of numbers, the patients are evaluated in two groups. The second group receives only Ketorolak ampoules.Patients will not know about the randomization method and the considered treatment protocol. Pain intensity is measured during the first 6 hours of recovery and the first 12 hours after the operation. In the group with moderate and severe pain, 10 and 20 mg of pethidine is injected, and the consumption of the two groups is compared. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyede zahra Seyf
No 1, East Payambar Ave, Abazar Blvd, Tehran
Tehran Iran (Islamic Republic of) 1473673341 +98 21 4496 5783 zahra.seyf7596@gmail.com Islamic Azad University scientific Seyede zahra Seyf
No 1, East Payambar Ave, Abazar Blvd, Tehran
Tehran Iran (Islamic Republic of) 1473673341 +98 21 4496 5783 zahra.seyf7596@gmail.com Islamic Azad University Iran (Islamic Republic of) Age over 18 years, undergoing all kinds of elective surgeries of the abdominal area under general anesthesia, anesthesia class one and two 18 years no limit Both 1- Existence of any disease limiting the use of NSAID (patients with gastrointestinal, liver, kidney disorders) 2- Incidence of surgery and anesthesia complications Treatment - Drugs Treatment - Drugs intervention group: In this double-blind randomized clinical trial study, patients undergoing elective abdominal surgery with general anesthesia who are in anesthesia class 1 and 2 were interviewed before surgery and background information including gender, age, clinical and medication records were obtained from them. The question is recorded in the study checklist. After complete preparation, placement of intravenous line, monitoring and receiving oxygen for 3 to 5 minutes with premedication of midazolam 2 mg and fentanyl 2 cc and sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg under anesthesia induction. They are placed and then anesthesia is administered with N2O gas and isoflurane oxygen and repetition of fentanyl and atracurium. At the end of the operation and randomly using a random table of numbers, the patients are evaluated in two groups. The first group receives diclofenac suppositories (100 mg each) and Ketorolac ampoules (15 mg) in the form of infusion. Patients will not know about the randomization method and the considered treatment protocol. Pain intensity is measured during the first 6 hours of recovery and the first 12 hours after the operation. In the group with moderate and severe pain, 10 and 20 mg of pethidine is injected, and the consumption of the two groups is compared. intervention group: In this double-blind randomized clinical trial study, patients undergoing elective abdominal surgery with general anesthesia who are in anesthesia class 1 and 2 were interviewed before surgery and background information including gender, age, clinical and medication records were obtained from them. The question is recorded in the study checklist. After complete preparation, placement of intravenous line, monitoring and receiving oxygen for 3 to 5 minutes with premedication of midazolam 2 mg and fentanyl 2 cc and sodium thiopental 5 mg/kg and atracurium 0.5 mg/kg under anesthesia induction. They are placed and then anesthesia is administered with N2O gas and isoflurane oxygen and repetition of fentanyl and atracurium.At the end of the operation and randomly using a random table of numbers, the patients are evaluated in two groups. The second group receives only Ketorolak ampoules.Patients will not know about the randomization method and the considered treatment protocol. Pain intensity is measured during the first 6 hours of recovery and the first 12 hours after the operation. In the group with moderate and severe pain, 10 and 20 mg of pethidine is injected, and the consumption of the two groups is compared. Type of medicine, pain intensity, sex, age, type of surgery. Timepoint: Recovery, the first 6 hours and the first 12 hours after the operation. Method of measurement: Visual Analogue Scale. Islamic Azad University Approved 2022-12-31 Ethics Committee of Tehran Islamic Azad University of Medical Sciences No1, East Payambar Ave, Abazar Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)