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IRCT20190202042595N1 IRCT 2019-02-13 Rafsanjan University of Medical Sciences The effect of acetaminophen and pethidine on reducing the pain of the first stage of labor and its complications in primipara women Comparison of the effectiveness of acetaminophen and pethidine in the first stage of labor on reducing the pain and maternal complications of primigravid women 2018-12-24 anticipated 100 Complete https://irct.ir/trial/37355 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random blocking and hiding the assignment of the type of intervention by writing the type of intervention on paper and placing in sealed envelopes that are numbered sequentially, Blinding description: The participant and the person evaluating the variables on which each individual is assigned will not be informed and for hiding the assignment of the type of intervention, the title of the intervention will be written on the paper, and the sealed envelopes are sequentially numbered and placed inside the envelope. 2 Delivery. Intervention 1: First Intervention group: Acetaminophen receptor, 100 mg of acetaminophen in 100 cc serum ringer lactate within 15 minutes. Intervention 2: Second Intervention group: Pethidine, 50 mg pethidine within 2 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 There is no more information
public Masoume Khammar
Maternity of Niknafas Hospital, Shodaha St.
Kerman Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 masoume.khammar@rums.ac.ir Rafsanjan University of Medical Sciences scientific Masoume Khammar
Shohada St.
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 Masoume.khammar@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Single with cephalic presentation Pregnant women requesting a reduction in labor pain no limit no limit Female Underlying disease(cardiac, hepatic, renal, pulmonary) Preeclampsia Diabetes Drug abuse Sensitization to acetaminophen and opioids G6PD deficiency Cesarean section history o80 Single spontaneous delivery Prevention Prevention First Intervention group: Acetaminophen receptor, 100 mg of acetaminophen in 100 cc serum ringer lactate within 15 minutes Second Intervention group: Pethidine, 50 mg pethidine within 2 minutes Pain. Timepoint: Before drug administration, 30 minutes, 1, 2, 3 and 4 hours after drug administration. Method of measurement: Visual analog scale(VAS) by graded ruler (0 to 10), which zero is painless and 10 most severe pain states. Maternal complications. Timepoint: From the time of drug injection to 4 hours after delivery. Method of measurement: Nausea, vomiting, drowsiness, respiratory depression. Duration of the first stage of labor. Timepoint: Distilation time of 4 cm to complete dilatation. Method of measurement: minute. Rafsanjan University of Medical Sciences Approved 2018-12-25 Ethics committee of Refsanjan University of Medical Sciences Ethics Committee, Rafsanjan University of Medical Siences, Emam Ali Blvd., Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)