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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of paracetamol and tramadol | Experimental | Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min |
|
| Pethidine | Active Comparator | 75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pethidine | Drug | 75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | one hour after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Maternal adverse effects of the medications | from enrollment to 72 hours after birth |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zohar Nachum, Prof. | Contact | +972-547696562 | nachum_zo@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HaEmek MC | Recruiting | Afula | Israel |
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| Tramadol | Drug | Women will receive intravenous infusion of 100 ml containing 100 mg of tramadol over 15 min |
|
| Paracetamol 1 g | Drug | women will receive 50 ml containing 1000 mg of paracetamol IV over 15 min |
|
| First stage of labor duration (hours) | from enrollment to 72 hours after birth |
| The need for additional analgesia (Epidural, pethidine IV, nitrous) | from enrollment to 72 hours after birth |
| Fetal and neonatal outcomes | from enrollment to 72 hours after birth |
| Pregnancy outcomes | from birth up to 72 hours after birth |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008614 | Meperidine |
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
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