Comparison of the effect of Dexmedetomidine with intravenous Paracetamol on Pain induced by Propofol 4oc injection; A double-Blind Randomized Clinical Trial

Comparison of the effect of dexmedetomidine with intravenous paracetamol on Propofol injection pain

Double-Blind Randomized Clinical Trial, Phase 3 on 90 patients, Web-based randomization software was used for randomization.

The present study will be conducted in the context of reducing Propofol injection pain in 90 patients aged 18-60 years who are candidates for surgery under general anesthesia at Imam Ali Hospital, North Khorasan University of Medical Sciences. Patients are divided into three groups in a blocked random allocation using the web-based system. Pain assessment will be done by a visual analog scale and Numeric rating scale measurement tool about 5 to 10 seconds after the injection of the targeted dose of Propofol. To perform blinding, the patients, the surgeon, and the person performing the evaluation at different intervals will be blinded to the groups.

Inclusion criteria: patients must be alert. Be candidate for surgery under general anesthesia. Do not have heart diseases. Has not taken painkillers In 24 hours before surgery. Exclusion criteria: Do not be allergic to the drugs in the study.

In the first group of patients, they receive Dexmedetomidine (0.5 μg/kg) slowly over a period of 5 minutes. In the second group of patients, Paracetamol (at the rate of 2 mg/kg) is slowly received over a period of 5 minutes. In the third group of patients, they receive Lidocaine (40 mg diluted in 10 cc of water) slowly over a period of 3 minutes. All injection will be done through a tee connector.

Pain during Propofol injection

Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 6. So that in each block, there are 2 people in the first group (A), two people in the second group (B) and two people in the third group (C). After a random sequence was identified in all blocks, cards were written by writing C, B, and A to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 90 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group.

None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Also, in order to blind the patients to the study groups, all patients will receive the desired drugs intravenously and In order to blind the anesthetist nurse (who is responsible for injecting drugs intravenously for patients), the arms of all patients will be covered with a cloth.

There is no further information.