Efficacy and Safety of Intravenous Paracetamol Compared With Intramuscular Tramadol for Labour Analgesia: A Randomised Comparative Study
Abstract
Introduction: Labour pain is a major source of maternal distress, particularly in settings where epidural analgesia is not routinely available. This study primarily compared the change in labour-pain intensity from baseline to one hour after intravenous paracetamol or intramuscular tramadol and secondarily compared labour, maternal safety and neonatal outcomes.
Methods: This was a prospective, single-blind, randomised controlled trial conducted in the Department of Obstetrics and Gynaecology, Nil Ratan Sircar Medical College and Hospital, Kolkata, India. A total of 11,002 healthy primigravidae aged 18-35 years in spontaneous labour were randomised to receive either intravenous paracetamol 1 g (n = 5,499) or intramuscular tramadol 100 mg (n = 5,503). Pain intensity was assessed using the Visual Analogue Scale before drug administration and at 10 minutes and one hour after administration. Labour duration, mode of delivery, maternal adverse events, and neonatal outcomes were recorded. Analyses were performed using both per-protocol (n = 9,945) and intention-to-treat approaches. Relative risks with 95% confidence intervals were calculated where appropriate.
Results: Both intravenous paracetamol and intramuscular tramadol significantly reduced labour pain. Tramadol produced slightly lower Visual Analogue Scale scores at 10 minutes and one hour, indicating marginally greater analgesic efficacy. However, tramadol was associated with higher maternal adverse effects, including nausea…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 9,945 participants or records.
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