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Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor

Study acronym: TRAMPA
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated February 27, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
This randomized, double-blind, placebo-controlled trial aims to compare the analgesic efficacy and obstetric effects of tramadol (100 mg IV) versus paracetamol (1 g IV) versus placebo (saline solution) in nulliparous women during active labor. The primary outcome is duration of active labor (minutes). Secondary outcomes include duration of expulsive phase, type of delivery, need for oxytocin augmentation, maternal adverse events (nausea, vomiting, somnolence, hypotension), and neonatal outcomes (Apgar scores at 1 and 5 minutes, NICU admission). The study hypothesizes that tramadol significantly reduces active labor duration compared to paracetamol and placebo, without compromising maternal or neonatal safety. A total of 300 nulliparous women (100 per group) will be enrolled at Hospital Escuela, Tegucigalpa, Honduras.
Trial Details
NCT Number NCT07440069
Lead Sponsor Universidad Nacional Autonoma de Honduras
Conditions
(from sponsor)		 Labor Pain
Related terms Labor Pain
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov