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IRCT20220903055861N1 IRCT 2023-06-06 Alborz University of Medical Sciences The comparison between high dose suppository Diclofenac and Pethidine in post cesarean section pain relief DPK The comparison between high dose suppository Diclofenac and Pethidine in post cesarean section pain relief 2023-08-23 anticipated 90 Complete https://irct.ir/trial/65769 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the block randomization method will be used to reach the same sample size in all 3 groups. In order to hide the allocation of unequal size blocks, it will be considered in the form of 3, 6, and 9 blocks. The randomization list will be provided using the web-based software provided at the following URL. https://www.sealedenvelope.com/simple-randomiser/v1/lists There is no possibility of blinding the patient, but the researcher evaluating the results and the data analyst will not be informed about the assigned groups. 2-3 Post C-section pain. Intervention 1: Intervention group: 200 mg diclofenac suppository. Intervention 2: Intervention group: Intramuscular injection pethidine g/mg1. Intervention 3: Control group: 100 mg diclofenac suppository. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: . Where to obtain: Dr. Elham Sadat Oliaei Elhamoliaei70@gmail.com How to obtain: After receiving the email from the applicants and approval by Alborz University of Medical Sciences, information will be sent within 6 months Comments:
public Elham sadat Oliaei
Unit 38, No. 9, Moradi Alley, North Adel Blvd., Ponk, Tehran
Tehran Iran (Islamic Republic of) 1476757811 +98 919 878 9818 elhamoliaei70@gmail.com Alborz University of Medical Sciences scientific Maryam Hashemnejad
Kamali alley, Shahid-Beheshti Blvd
Karaj Iran (Islamic Republic of) 3134877179 +98 26 3226 6851 elhamoliaei70@gmail.com Alborz university of Medical Sciences Iran (Islamic Republic of) Full-term Pregnant women Aside C-section indication Full-term alive neonate Age between 18 and 45 year Participation consent 18 years 45 years Female Patients who show an allergic reaction to the drug will be excluded from the study History of allergy to NSAID and pethidine Bronchial asthma Drug addiction, alcohol abuse, opium addict or the use of any drug that impairs the perception of pain Proctitis Coagulopathy Gastrointestinal tract ulcers, stomach ulcers, history of gastrointestinal bleeding Long-term steroid treatment or continuous use of painkillers Neurological or psychological disorders Users of medications that interact with pethidine, such as MAO inhibitors (e.g., isocarboxazid , methylene blue, linezolid), certain pain medications (e.g., pentazocine, nalbuphine, butorphanol), seizure medications (e.g., carbamazepine, phenytoin) Liver and kidney diseases Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: 200 mg diclofenac suppository Intervention group: Intramuscular injection pethidine g/mg1 Control group: 100 mg diclofenac suppository Patient's pain according to visual measurement criteria. Timepoint: 2 and 6 hour after C-section. Method of measurement: Visual measurement criteria. Drowsiness. Timepoint: 2 and 6 hour after C-section. Method of measurement: Glasgow Coma Scale. Hypotension. Timepoint: 2 and 6 hour after C-section. Method of measurement: Sphygmomanometer. Abnormal bleeding. Timepoint: 2 and 6 hour after C-section. Method of measurement: Physical exam. Respiratory disfunction. Timepoint: 2 and 6 hour after C-section. Method of measurement: Spirometry and clinical examination. Alborz University of Medical Sciences Approved 2023-05-14 Ethics committee of Alborz University of Medical Sciences Kamali hospital, Kamali alley, Shahid-Beheshti Blvd Karaj Alborz Iran (Islamic Republic of)