IV tramadol plus paracetamol versus IM pethidine for pain relief during the first stage of labor
Official title: Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor
Run by HaEmek Medical Center, Israel · NCT07264309 · Data updated 2026-11-12
This trial will test whether IV tramadol (100 mg) combined with paracetamol (1,000 mg) relieves pain better and with fewer side effects than 75 mg IM pethidine for women in the first stage of labor.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT07264309 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Term pregnant women with a singleton pregnancy in the first stage of labor (at least four painful contractions in 30 minutes and cervical dilation ≤1 cm or 50% effacement) who meet inclusion criteria and none of the exclusions are ideal candidates.
✕Probably not a fit
Women who meet any exclusion criteria (for example prior cesarean, multiple pregnancy, suspected placental abruption or fetal compromise, significant cardiac/liver/renal disease, MAOI or anticonvulsant use, or morbid obesity) would not be eligible and therefore would not receive potential benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Term pregnant women in the first stage of labor will receive either 75 mg intramuscular pethidine or a combination of 100 mg IV tramadol and 1,000 mg IV paracetamol, with pain scores recorded before dosing and one hour afterward. Fetal heart rate and uterine contractions will be monitored with cardiotocography for at least 20 minutes prior to drug administration, and maternal vigilance will be assessed 30 minutes after dosing. The primary outcome is change in numeric rating scale (NRS) pain score; adverse effects for mother and fetus will also be recorded. The protocol excludes women with prior cesarean, multiple gestation, suspected placental or fetal compromise, significant comorbidities, or certain medication interactions.
Why it matters
Potential benefit: If successful, the IV tramadol-plus-paracetamol combination could provide better pain relief with fewer maternal or neonatal side effects during early labor.
How similar studies have gone: Pethidine has a long history of use for labor analgesia while IV tramadol combined with paracetamol has been less commonly studied in labor, so evidence for this exact combination in first-stage labor is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
HaEmek MC
Afula, Israel Recruiting
Study contacts
- Study coordinator: Zohar Nachum, Prof.
- Email: nachum_zo@clalit.org.il
- Phone: +972-547696562
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.