Comparison of analgesic effect of remifentanil versus combination of apotel and pethidine on labor pain among mothers candidate for normal vaginal delivery

Comparison of analgesic effect of remifentanil versus combination of apotel and pethidine in labor pain control

In this double-blind clinical trial, phase 2, 100 pregnant women who meet the inclusion criteria are placed in parallel groups in two groups of 50 in a simple random sampling method using a random number table. Patients are explained about the treatment methods, their benefits and side effects and informed consent will be obtained.

This study will be performed in Alavi Hospital of Ardabil in mothers who are candidates for natural childbirth in the maternity ward. The study will be double-blind; In this study, placebo and drugs are in the same package and patients and clinical caregivers are unaware of the type of drug received.

Inclusion criteria: Over 37 weeks pregnancy, first or second pregnancy, singleton. Non-inclusion criteria: Malpresentation of fetus, macrosomia.

Intervention group 1: 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. 2: 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

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.

In this study, placebo and drugs are in the same package and participants and clinical caregivers are not aware of the type of medication.