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IRCT20220116053734N1 IRCT 2022-12-08 Qazvin University of Medical Sciences Evaluation of the effect of paracetamol with Entonox in comparison with pethidine with Entonox on labor pain Evaluation of the effect of paracetamol with Entonox in comparison with pethidine with Entonox on labor pain 2022-12-22 anticipated 100 Complete https://irct.ir/trial/61695 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to two treatment groups A and B using the balanced block randomization method through https://www.sealedenvelope.com/simple-randomiser/v1/lists. The size of each block is 4 and the total number of blocks is 25. Balanced randomization allocation for the participants in the current study, the effect of Paracetamol with Entonox (A) and Pethidine with Entonox (B) on labor pain is investigated, Blinding description: Checklist information is provided by the secretary of the department in which people with file number are registered to the person responsible for the analysis and statistical analysis of the plan. After entering SPSS and coding 1 and 2, the results of the evaluation will be analyzed by the statistician, separated into paracetamol receiving and pethidine receiving groups (which only the secretary of the department knows about). Therefore, the researcher and evaluator are not aware of the trend of pain during labor, and the statistician is not aware of which analgesic drug the patient received. The data analyst and the safety monitoring committee are not aware of which drugs the patients took. 3 Pain during labor. Intervention 1: first Intervention group: Infusion of acetaminophen, 1 g, 6.7 ml, Caspian company, in 100cc of N/S, with 300 gtt/min + entonox gass inhalation. Intervention 2: second Intervention group: Infusion of pethidin, 50 mg, 1 ml, Exir company, in 100cc of N/S, with 300 gtt/min + entonox gass inhalation. Yes - There is a plan to make this available What will be shared: Patient unidentifiable individuals data and the final clinical study report can be released. When: Releasing after one year of publication of the study results To whom: Academic-scientific institutions Conditions: The use of data and results is permitted for future scientific research. Where to obtain: Receive data by email to the researcher ensiehr8@gmail.com How to obtain: About a month after sending the request Comments:
public Ensiyeh Rajabpour
Qazvin university of medical science, Bahonar Blvd
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6001 medicine@qums.ac.ir Qazvin University of Medical Sciences scientific Ensiyeh Rajabpour
Qazvin university of medical science, Bahonar Blvd
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6001 medicine@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Patients should be between 18 and 45 years old. The fetal presentation should be cephalic. Fetuses are single. Dilatation of the uterus should be 4 cm. 18 years 45 years Female Having a fetal growth disorder Having a history of chronic pain Having an addiction to drugs, alcohol and smoking Having indications for cesarean section Havind a history of severe psychological disorders, cardiovascular, renal, respiratory, asthma, diabetes, hypertension, coagulation disorders and epilepsy in mother Treatment - Drugs Treatment - Drugs first Intervention group: Infusion of acetaminophen, 1 g, 6.7 ml, Caspian company, in 100cc of N/S, with 300 gtt/min + entonox gass inhalation second Intervention group: Infusion of pethidin, 50 mg, 1 ml, Exir company, in 100cc of N/S, with 300 gtt/min + entonox gass inhalation Labor pain score. Timepoint: before drug injection and 15, 30, 45, 60 and 120 minutes after drug injection. Method of measurement: pain NRS numerical rating scale. The time between drug injection and delivery. Timepoint: Drug injection time and fetus delivery time. Method of measurement: time. Placenta delivery time. Timepoint: delivery time and placenta delivery time. Method of measurement: time. Newborn Apgar score. Timepoint: 1 and 5 minutes after labor. Method of measurement: Apgar score. Mother hemoglobin level. Timepoint: Before delivery and 6 hours after delivery. Method of measurement: Hemoglobin. Drug side effects in the mother including headache/dizziness/blurred vision/dry mouth/nausea/vomiting/dyspnea. Timepoint: During the time of drug injection until delivery. Method of measurement: Ask the patient. Qazvin University of Medical Sciences Approved 2021-05-29 Ethics committee of Qazvin University of Medical Sciences Kosar hospital, Taleghani st, Valiasr Blvd Qazvin Qazvin Iran (Islamic Republic of)