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IRCT20220430054707N1 IRCT 2022-08-11 Zanjan University of Medical Sciences comparison of the effect of intravenous and subcutaneous dexamethasone on the prevention of pain after cesarean section comparison of the effect of intravenous and subcutaneous Dexamethasone on prevention of pain after caesarian section 2022-09-06 anticipated 156 Complete https://irct.ir/trial/64012 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: In this study, we will use the block randomization method. The size of all blocks is equal and will be 9 (including three participants in first intervention group, three participants in second intervention group, and three participants in the control group). Random allocation software is also used to generate a random sequence of blocks, Blinding description: In this study, due to intervention during surgery, those responsible for data collection and those who evaluate the outcome and those who prepare the draft of the article will be completely unaware of the treatment protocol, because records will be completed as numbers (1, 2 or 3). 3 post operative caesarian pain. Intervention 1: Intervention 1: Eight milligrams of intravenous dexamethasone produced by Abidi Pharmaceutical Factory will be given as a single dose immediately after spinal anesthesia. Intervention 2: Intervention group 2: Eight mg subcutaneous dexamethasone product of Abidi Pharmaceutical Factory will be administered to the patient as a single dose at the end of the procedure before the skin incision closure. Intervention 3: Control group: Without dexamethasone administration. Yes - There is a plan to make this available What will be shared: Part of the data including the main and secondary outcomes can be shared. When: Access period starts from 2023 To whom: Researcher in academic and scientific institutions Conditions: Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals. Where to obtain: Research Committee of the Vice Chancellor for Research and Technology How to obtain: To submit a request, it is enough to contact the responsible person of the project and send a written and signed request to her. Comments:
public Batoul Ahmadi
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3313 0001 Ahmadi.batoul@zums.ac.ir Zanjan University of Medical Sciences scientific Batoul Ahmadi
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3313 0001 Ahmadi.batoul@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Candidate for non-emergency cesarean section Not having allergy to dexamethasone Age between20-45 Not having contraindications to spinal anesthesia 20 years 45 years Female Prolongation of cesarean section more than 2 hours Convert spinal anesthesia to general for any reason. O75.82 Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section Treatment - Drugs Treatment - Drugs N/A Intervention 1: Eight milligrams of intravenous dexamethasone produced by Abidi Pharmaceutical Factory will be given as a single dose immediately after spinal anesthesia. Intervention group 2: Eight mg subcutaneous dexamethasone product of Abidi Pharmaceutical Factory will be administered to the patient as a single dose at the end of the procedure before the skin incision closure. Control group: Without dexamethasone administration Pain after surgery. Timepoint: During the first 24 hours after surgery, patients' pain will be assessed every 2 hours for six hours and then every six hours. Method of measurement: The pain intensity of patients will be measured using a visual analog measurement system (VAS). ŮŽApgar of neonate. Timepoint: First, Fifth and Ten minutes after birth. Method of measurement: Using the newborn Apgar scoring system. Zanjan University of Medical Sciences Approved 2022-05-31 Ethics Committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan Zanjan Zanjan Iran (Islamic Republic of)