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IRCT20120215009014N455 IRCT 2022-12-29 Hamedan University of Medical Sciences Comparison of the effect pethidine, paracetamol and their combination on the reduction of labor pain and the level of satisfaction of primiparous women Comparison of the effect pethidine, paracetamol and their combination on the reduction of labor pain and the level of satisfaction of primiparous women 2023-01-21 anticipated 111 Complete https://irct.ir/trial/67644 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare three sheets of paper, writing on one sheet the name of the intervention 1 and on another sheets the name of the intervention 2 and on the third sheet the name of the intervention 3. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The three paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 3 Labor pain. Intervention 1: Intervention group 1: Infusion of one gr of paracetamol plus 100 ml of normal saline over 20 minutes. Intervention 2: Intervention group 2: Infusion of 25 mg of pethidine plus 100 ml of normal saline over 20 minutes. Intervention 3: Intervention group 3: Infusion of one gr of paracetamol and 25 mg of pethidine plus 100 ml of normal saline over 20 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Dr Hamideh Parsapour
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 h.parsapour@umsha.ac.ir Hamedan University of Medical Sciences scientific Dr Hamideh Parsapour
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 h.parsapour@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 40 years Term pregnancy A singleton with a cephalic display Cervical dilatation 4 cm Pregnant women undergoing induction of labor with oxytocin 18 years 40 years Female Analgesic consumption in the last 24 hours Preeclampsia and eclampsia Severe obesity Intrauterine fetal death Fetal abnormalities O75.0 Maternal distress during labor and delivery Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Infusion of one gr of paracetamol plus 100 ml of normal saline over 20 minutes Intervention group 2: Infusion of 25 mg of pethidine plus 100 ml of normal saline over 20 minutes Intervention group 3: Infusion of one gr of paracetamol and 25 mg of pethidine plus 100 ml of normal saline over 20 minutes Labor pain intensity. Timepoint: In the first and fifth minutes after delivery. Method of measurement: Using visual analog scale (VAS). The level of satisfaction. Timepoint: After the third stage of labor. Method of measurement: Using McKay's satisfaction questionnaire. Side effects (nausea, vomiting, maternal tachycardia, respiratory depression, drowsiness, itching). Timepoint: In the first, second and third stage of labor. Method of measurement: With clinical examination and history taking. Hamedan University of Medical Sciences Approved 2022-09-10 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)