Birth, Pain Management
Conditions
Brief summary
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
Interventions
DRUGpethidine
75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the
DRUGTramadol
Women will receive intravenous infusion of 100 ml containing 100 mg of tramadol over 15 min
DRUGParacetamol 1 g
women will receive 50 ml containing 1000 mg of paracetamol IV over 15 min
Sponsors
Zohar Nachum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor -
Exclusion criteria
* Previous cesarean delivery * Malpresentation * Multiple pregnancies * Suspected intrauterine growth restriction \< 3 percentile * Suspected placental abruption * History of allergy to paracetamol, tramadol or pethidine * Women with sleep apnea disorder * Morbid obesity BMI≥40 * History of significant cardiac, liver and renal diseases * Anti-convulsive medication consumption * MAO inhibitors medication consumption within the last 14 days * Non reassuring fetal heart rate monitoring (type II or III) * Tense use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect on pain relief | one hour after drug administration. | according to numeric rating scale (NRS), which runs from 0-10, where 0 is no pain and 10 is the worst pain. |
Secondary
| Measure | Time frame |
|---|---|
| Maternal adverse effects of the medications | from enrollment to 72 hours after birth |
| First stage of labor duration (hours) | from enrollment to 72 hours after birth |
| Women satisfactory rate by NRS- a scale between 1-5, where 1 is no satisfactory and 5- is excellent satisfactory | from enrollment up to 72 hours after the birth |
| Fetal and neonatal outcomes | from enrollment to 72 hours after birth |
| Pregnancy outcomes | from birth up to 72 hours after birth |
| The need for additional analgesia (Epidural, pethidine IV, nitrous) | from enrollment to 72 hours after birth |
Countries
Israel
Contacts
Primary ContactZohar Nachum, Prof.
Outcome results
None listed