The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol. The investigator assume that the combination of IV tramadol and paracetamol will be more effective with less adverse effects than IM pethidine in pain relief at the first stage of labor. The investigator primary outcome is The effect on pain relief according to numeric rating scale (NTS) in the study groups Before the administration of the drugs, fetal heart rate patterns and contractions will be recorded with cardiotocography monitor for at least 20 min. The investigator will evaluate vigilance at 30 minutes following drug administration. NRS pain score (0-10) will be collected before administration and one hour after drug administration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the
Women will receive intravenous infusion of 100 ml containing 100 mg of tramadol over 15 min
women will receive 50 ml containing 1000 mg of paracetamol IV over 15 min
HaEmek MC
Afula, Israel
RECRUITINGThe effect on pain relief
according to numeric rating scale (NRS), which runs from 0-10, where 0 is "no pain" and 10 is the "worst pain.
Time frame: one hour after drug administration.
Women satisfactory rate by NRS- a scale between 1-5, where 1 is no satisfactory and 5- is excellent satisfactory
Time frame: from enrollment up to 72 hours after the birth
Maternal adverse effects of the medications
Time frame: from enrollment to 72 hours after birth
First stage of labor duration (hours)
Time frame: from enrollment to 72 hours after birth
The need for additional analgesia (Epidural, pethidine IV, nitrous)
Time frame: from enrollment to 72 hours after birth
Fetal and neonatal outcomes
Time frame: from enrollment to 72 hours after birth
Pregnancy outcomes
Time frame: from birth up to 72 hours after birth
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