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IRCT20240808062692N1 IRCT 2025-01-02 Shiraz University of Medical Sciences Evaluating The Role of Intravenous Ketorolac in Preventing Post-Operative Pain in Patients Undergoing hemorrhoidectomy Evaluating The Role of Intravenous Ketorolac in Preventing Post-Operative Pain in Patients Undergoing hemorrhoidectomy: a clinical trial 2024-09-22 anticipated 60 Complete https://irct.ir/trial/78564 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: block randomization method randomizing participants within blocks such that an equal number are assigned to each treatment we have 30 cases (patients receiving ketorolac) and 30 controls (patients not receiving ketorolac). We'll use block randomization to ensure balanced groups. Here's how you can do it: Determine Block Size: Let's choose a block size of 6 (you can adjust based on preference). This will mean each block contains an equal number of cases and controls. Create Block Sequences: For a block size of 6, you have these possible sequences: KKKCCC KKCKCC KKCCKC KCCKKC CCKKKC CCKCKK CCKCKK CCCKKK and so on... Randomize Block Selection: Randomly select one of these sequences for each block of 6 participants. Assign Participants: As participants are enrolled, assign them to treatment groups according to the selected block sequence. Repeat this process for each new block until all participants are assigned. Here's a simplified example of how it might look for the first few blocks: Block Number Block Sequence Participant Assignments Block 1 KKKCCC 1-K, 2-K, 3-K, 4-C, 5-C, 6-C Block 2 KKCCKC 7-K, 8-K, 9-C, 10-C, 11-K, 12-C Block 3 CKCKKC 13-C, 14-K, 15-C, 16-K, 17-K, 18-C ... ... ... Repeat this until all 60 participants are assigned. This method ensures each group has a balanced number of participants, reducing bias and improving the reliability of your results, Blinding description: the patients would not know which group they are and the physician assessing them post-operation also is unaware whether the patient is in the control or case group A clinical trial design in which neither the participants nor investigators know which participants are receiving the experimental medicine and which are receiving a placebo (or comparator therapy). Double-blind trials are thought to produce objective results, since the expectations of the investigator and the participant do not affect the outcome. Also called double-masked trial. Considered best-controlled trial design. Decreased chance of preconceived notions or physical cues (e.g. the placebo effect, observer bias, experimenter's bias) to distort the results. The key that identifies the participants and which group they belonged to is kept by a third party, and is not revealed to the researchers until the study is over. Should be used whenever possible. In trials in studies comparing two active compounds (test medicine and comparator) and when the two treatments cannot be made identical, double dummy is a technique for retaining the blind. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Participants then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active). For example, if we want to compare two medicines, one presented as green tablets and one as pink capsules, we could also supply green placebo tablets and pink placebo capsules so that both groups of patients would take one green tablet and one pink capsule. 3 hemorrhoid. Intervention 1: Intervention group: The case group received 30 mg ketorolac intravenously immediately before induction of anesthesia and received pethidine after the operation if needed. The intensity of pain one and four hours after the operation in case group is evaluated by asking the patients to give a pain score from 0 (no pain) to 10 (severe pain). The intensity and duration of pain, the type and dosage of postoperative painkillers, the type and dosage of sedatives, blood pressure, heart rate, and the demographic information of the patients are recorded. The patients do not know which group they belong to, and the doctor evaluates them after the operation. He also does not know whether the patient is in the control or case group. Intervention 2: Control group: The control group did not receive any medication before the induction of anesthesia and received pethidine after the operation if needed. The intensity of pain one and four hours after the operation in the control group is evaluated by asking the patients to give a pain score from 0 (no pain) to 10 (severe pain). The intensity and duration of pain, the type and dosage of postoperative painkillers, the type and dosage of sedatives, blood pressure, heart rate, and the demographic information of the patients are recorded. The patients do not know their group, and the doctor evaluates them after the operation. He also does not know whether the patient is in the control or case group. Yes - There is a plan to make this available What will be shared: Whole data When: 6 months after publication To whom: Everyone Conditions: No conditions are required Where to obtain: Hooman Rezaei Email : hoomanr2000@gmail.com How to obtain: email the publisher and you can have the data as soon as possible Comments:
public Hooman Rezaei
Zand street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 hoomanr2000@gmail.com Shiraz University of Medical Sciences scientific Hooman Rezaei
Zand street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 hoomanr2000@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) patients with planned hemorrhoidectomy who are referred to Namazi hospital, Shiraz, Iran 18 years no limit Both drug addiction positive history of anxiety disorder or mental problems or sensory problems thrombotic hemorrhoids whom underwent local or spinal anesthesia K64.2 Third degree hemorrhoids Prevention Prevention Intervention group: The case group received 30 mg ketorolac intravenously immediately before induction of anesthesia and received pethidine after the operation if needed. The intensity of pain one and four hours after the operation in case group is evaluated by asking the patients to give a pain score from 0 (no pain) to 10 (severe pain). The intensity and duration of pain, the type and dosage of postoperative painkillers, the type and dosage of sedatives, blood pressure, heart rate, and the demographic information of the patients are recorded. The patients do not know which group they belong to, and the doctor evaluates them after the operation. He also does not know whether the patient is in the control or case group. Control group: The control group did not receive any medication before the induction of anesthesia and received pethidine after the operation if needed. The intensity of pain one and four hours after the operation in the control group is evaluated by asking the patients to give a pain score from 0 (no pain) to 10 (severe pain). The intensity and duration of pain, the type and dosage of postoperative painkillers, the type and dosage of sedatives, blood pressure, heart rate, and the demographic information of the patients are recorded. The patients do not know their group, and the doctor evaluates them after the operation. He also does not know whether the patient is in the control or case group. Pain degree. Timepoint: one and four and 24 hours after operation. Method of measurement: Subjective score of pain from ۰ (no pain) to ۱۰ (severe pain). Shiraz University of Medical Sciences Approved 2024-07-07 Ethics committee of Shiraz University of Medical Sciences Zand Street, Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)