Tramadol versus paracetamol versus placebo for pain relief and labor length in first-time mothers
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor: A Randomized Double-Blind Controlled Trial
This trial will try IV tramadol, IV paracetamol, or saline to see which gives better pain relief and changes active labor length for first-time mothers in active labor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras Academic / other |
| Locations | 2 sites (Tegucigalpa, Francisco Morazán Department and 1 other locations) |
| Trial ID | NCT07440069 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, three-arm trial enrolling 300 nulliparous women in active labor at two Tegucigalpa hospitals. Participants receive a single IV dose of tramadol 100 mg, paracetamol 1 g, or saline at onset of active labor (≥4 cm dilation) and are followed through delivery. The primary endpoint is duration of active labor from intervention to full dilation; secondary endpoints include expulsive phase length, delivery type, need for oxytocin, maternal adverse events, and neonatal outcomes such as Apgar scores and NICU admission. Allocation is concealed and blinded for participants, clinicians, and outcome assessors, with statistical comparisons planned between the three groups.
Who should consider this trial
Good fit: Ideal candidates are nulliparous pregnant women aged 15–45 with a singleton term cephalic pregnancy in active labor (cervical dilation ≥4 cm) who can give informed consent.
Not a fit: Women with high-risk pregnancies, recent analgesic use, prior uterine surgery, non-cephalic presentation, prolonged rupture of membranes, active infection/fever, or inability to consent are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could identify a safe, effective IV analgesic that shortens active labor and improves comfort for first-time mothers.
How similar studies have performed: Previous smaller trials and clinical experience suggest opioids like tramadol can reduce labor pain and sometimes shorten labor, while IV paracetamol has less consistent evidence for benefiting active labor.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous pregnant women * Age between 15 and 45 years * Singleton pregnancy, term (37-41 weeks gestation) * Cephalic presentation * Active labor defined as cervical dilation ≥4 cm with regular contractions * Signed informed consent Exclusion Criteria: * Multiple gestation or high-risk pregnancy (preeclampsia, gestational diabetes, etc.) * Known allergy or contraindication to tramadol or paracetamol * Recent use (less than 6 hours) of any analgesic medication * Previous cesarean section or other uterine surgery * Active infection or fever at admission * Inability to provide informed consent due to mental or communication conditions * Non-cephalic presentation * Rupture of membranes \>18 hours without labor * Participation in another clinical trial within the last 3 months
Where this trial is running
Tegucigalpa, Francisco Morazán Department and 1 other locations
- Hospital Escuela — Tegucigalpa, Francisco Morazán Department, Honduras (Recruiting)
- Instituto Hondureño de Seguridad Social — Tegucigalpa, Francisco Morazán Department, Honduras (Recruiting)
Study contacts
- Study coordinator: Ricardo A. Gutierrez-Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: +50497546940
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.