IV tramadol plus paracetamol versus IM pethidine for pain relief during the first stage of labor
Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Sex | Female |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Trial ID | NCT07264309 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Afula
- HaEmek MC — Afula, Israel (Recruiting)
Study contacts
- Study coordinator: Zohar Nachum, Prof.
- Email: nachum_zo@clalit.org.il
- Phone: +972-547696562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.