Objectives
One reason for higher tendency to cesarean delivery is delivery pain. If delivery pain don't relieved may cause maternal psychosocial health problems that impair maternal-neonatal relation and postpartum depression. The aim of this study is to compare intravenous fentanyl and intramuscular pethidine effects in pain control, as well as their side effects to find a suitable medication for delivery pain relieving and decreasing of C-section and prevention of its undesirable consequences.
Design
This study is a not blinded clinical trial and patients after informed consent for participation in the study was divided into two groups.
Setting and conduct
All subjects who have inclusion criteria were randomly divided in two groups (30 patients in each group) and therapeutic interventions performed on them.
Participants including major eligibility criteria,
Sixty women who referred for normal vaginal delivery in the first stage of labor (cervical dilatation of 4 cm to 10 cm) enrolled in study. Inclusion criteria are one fetus pregnancy; cephalic presentation; multiparty; GA: 38-40 wks; trend to painless delivery; patient Blood pressure>90 & heart rate>60; age 18-40 yr. Exclusion criteria including allergy to opium; drug abuse; Wt<50kg &Wt>100kg; high risk pregnancy: preeclampsia, severe asthma, insulin dependent diabetes, Cardiovascular disease, myasthenia gravis, epilepsy, liver and kidney diseases.
Intervention
First group receive 50 to 100 mcg per hour fentanyl as IV and second group pethidine 50 mg intramuscular for pain relieving which can repeated every 1 to 2 hours up to 100 mg.
Vital signs monitor and record every 30 minutes and the patient is monitored with a pulse oximeter. If the mother need to a c-section for any reason and her breathing rate is less than 8/min and heart rate less than 50/min and O2 saturation less than 90% for more than15 seconds and don't recovered by oxygen therapy, these conditions considered as severe complications, the drugs discontinued and the patient exclude from study. Also, if delivery takes place during 1 hour after injection the patient will exclude.
The prescribed procedures, control of vital signs and determining of pain score evaluate by resident and only anesthesia team will aware from the type of prescribed drugs.
Main outcome measures (variables)
Intense of pain evaluate before and after drug administration. 2 hours after delivery patient satisfaction assessed and recorded by 0-10 score.
Occurrence of symptoms including nausea, vomiting and itching, newborn Apgar score in first and fifth minutes, the need to naloxan and oxygen in newborn will be recorded.