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IRCT20210101049907N1 IRCT 2021-01-30 Ardabil University of Medical Sciences Effect of remifentale and a combination of apotel and Pethidine in reducing labor pain Comparison of analgesic effect of remifentanil versus combination of apotel and pethidine on labor pain among mothers candidate for normal vaginal delivery 2021-03-10 anticipated 100 Complete https://irct.ir/trial/53470 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method is a simple randomizing using a table of random numbers, a set of numbers which is completely generated randomly without any specific pattern or order in a table form. Table numbers are read from the left, in a way that even numbers are assigned to intervention A and odd numbers to intervention B. In this way, the researcher touches one of the numbers and moves to the right, then records the numbers and assigns them to different groups. Next, considering the volume of the research sample, aluminum wrapper envelopes are prepared (in order not to clarify the content of the envelopes), each of the random sequences is recorded on a card and placed inside an envelope. To maintain a random sequence, envelopes are numbered in the same way. Finally, the flap of the envelopes are sealed and respectively placed inside a box. To reveal the participants' assigned group, at the beginning of the registration based on the order of eligible participants entry to study, one of the envelopes is opened, Blinding description: In this study, placebo and drugs are in the same package and participants and clinical caregivers are not aware of the type of medication. 2-3 Labor pain. Intervention 1: Intervention group: Intravenous Remifentanil 0.05 μg/kg/min (Tofigh Daru Co.) and intravenous injection of placebo (6.7 ml) and 1 ml intramuscular injection of placebo. Intervention 2: Intervention group: Intramuscular injection of pethidine (50 mg / ml, Caspian Tamin Co.) and intravenous injection of paracetamol (1 g in 6.7 ml, Caspian Tamin Co.) and 2 ml of placebo intravenous injection. 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 Study results are not yet clear
public Zohre Roshani
Alavi Hospital, Moadi street, Ardabil
Ardabil Iran (Islamic Republic of) 5613974156 +98 45 3324 8888 z.roshani@arums.ac.ir Ardabil University of Medical Sciences scientific Zohre Roshani
Alavi Hospital, Moadi street, Ardabil
Ardabil Iran (Islamic Republic of) 5613974156 +98 45 3324 8888 z.roshani@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Over 37 weeks pregnancy First or second pregnancy Singleton no limit no limit Female Malpresentation of fetus Macrosomia O80 Encounter for full-term uncomplicated delivery Treatment - Drugs Treatment - Drugs Intervention group: Intravenous Remifentanil 0.05 μg/kg/min (Tofigh Daru Co.) and intravenous injection of placebo (6.7 ml) and 1 ml intramuscular injection of placebo Intervention group: Intramuscular injection of pethidine (50 mg / ml, Caspian Tamin Co.) and intravenous injection of paracetamol (1 g in 6.7 ml, Caspian Tamin Co.) and 2 ml of placebo intravenous injection Pain. Timepoint: Before analgesic administrations and two times (30 and 60 min) after intervention. Method of measurement: Visual analog scale. Apgar. Timepoint: 1 and 5 minutes after birth. Method of measurement: Apgar test. Ardabil University of Medical Sciences Approved 2020-07-06 Ethics committee of Ardabil University of Medical Sciences Ardabil University of Medicine Sciences, Daneshgah street, Ardabil Ardabi Ardabil Iran (Islamic Republic of)