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IRCT20110712007013N27 IRCT 2020-04-08 Tabriz University of Medical Sciences The effect of dexmedetomidine and paracetamol on postoperative pain of cesarean section with spinal anesthesia Comparing the effect of Dexmedetomidine-Paracetamol combination and placebo in prevention of postoperative pain in patients undergoing cesarean delivery with spinal anesthesia 2019-11-22 anticipated 100 Complete https://irct.ir/trial/46707 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software, Blinding description: The anesthesiologist who is responsible for the patients management to induce anesthesia will administer the medicine(s) via coded syringes which have been prepared previously and therefore he/she will not be aware of the injected drug. Meanwhile the anesthesia nurse who is responsible for collection of patients' information and study variables and is unaware of the administered drug will fill the check- list during surgery and in the recovery room. Also the patient is unaware of the injected medicine. 3 Acute postoperative pain. Intervention 1: Intervention group: In this group 1 gr Paracetamol and 1 mg/kg Dexmedomidine in 100 ml normal saline is infused 15 minutes before the end of the surgery. Intervention 2: Control group: In this group only normal saline (as placebo) which is as the same as the drug in the intervention group in shape and color will be prescribed 15 minutes before the end of the surgery. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: starting 6 months after publication To whom: All Physicians and residents of the Anesthesia field Conditions: There will be no specific limitation to the utilization of the data. Where to obtain: Dr .Simin Atashkhoei; Al-Zahra Hospital; South Artesh Street; Tabriz; East Azarbaijan; Islamic Republic of Iran. Phone number: +98 41 1553 9161; Fax number: +98 41 1556 6449. Email address: siminatashkhoii@yahoo.com How to obtain: Being approved by the Research and Technology deputy at first Comments:
public Dr. Simin Atashkhoyi
Al-Zahra Hospital, South Artesh street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3553 9161 satashkhoyi@gmail.com Tabriz University of Medical Sciences scientific Dr. Simin Atashkhoyi
Al-Zahra Hospital, South Artesh street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3553 9161 satashkhoyi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Pregnant women between the ages of 18 and 60 years old ASA class one and two Candidates for elective cesarean section or spinal anesthesia 18 years 40 years Female Sensitivity to the compounds used for intervention group Mental illness Patients with cardiovascular, pulmonary, liver and kidney and ...disease Multiple pregnancy Urgent cesarean G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group: In this group 1 gr Paracetamol and 1 mg/kg Dexmedomidine in 100 ml normal saline is infused 15 minutes before the end of the surgery. Control group: In this group only normal saline (as placebo) which is as the same as the drug in the intervention group in shape and color will be prescribed 15 minutes before the end of the surgery. Pain. Timepoint: At post-anesthesia care unit and at 1, 3, 6, 12 and 24 hours after surgery. Method of measurement: Visual analogue scale (VAS) (from 0= no pain to 10= severe pain). Overall dose of postoperative analgesic. Timepoint: At post-anesthesia care unit and during 24 hours after surgery. Method of measurement: Number and amount of medication by mg, based on patient's record. Tabriz University of Medical Sciences Approved 2019-11-25 Ethics Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)