Evaluating The Role of Intravenous Ketorolac in Preventing Post-Operative Pain in Patients Undergoing hemorrhoidectomy: a clinical trial

Evaluating The Role of Intravenous Ketorolac in Preventing Post-Operative Pain in Patients Undergoing Hemorrhoidectomy in Namazi Hospital, Shiraz, Iran in 1403

control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients with randomized block method. After ethical approval and consent, we perform randomization and blinding to reduce bias. Continuously monitor the vital signs and report findings.

The case group will receive ۳۰ mg ketorolac intravenously just before anesthesia induction and the control group would receive pethidine post-operation, as needed. pain severity assessed in one and four hours after operation in both case and control groups by give a score to their pain from ۰ (no pain) to ۱۰ (severe pain). Pain severity and duration, type and dose of post-op analgesic use, type and dose of sedative drug, blood pressure, heart rate, patients’ demographic data will be recorded. patients and physician assessing them post-op are unaware whether the patient is in the control or case group

patients with planned hemorrhoidectomy in Namazi hospital, Shiraz, Iran. Patients with drug addiction, positive history of anxiety disorder, mental problems, sensory problems, thrombotic hemorrhoids, or who underwent local or spinal anesthesia will be excluded from the study.

The control group will undergo routine care for post-hemorrhoidectomy operations, but the case group will receive ۳۰ mg of Ketorolac intravenously before the operation.

pain degrees evaluated by asking patients to give a score from ۰ (no pain) to ۱۰ (severe pain). duration of pain assessed in both groups. Pain severity and duration, type and dosage of post-op analgesic use, type and dose of sedative drug, blood pressure, heart rate, along with patients’ demographic data will be recorded.

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.

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.

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Hooman Rezaei Email : hoomanr2000@gmail.com

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