A Randomized Controlled Trial of Intravenous Paracetamol and Intravenous Tramadol for Labour Analgesia

Abstract

Background: Labour pain described as ‘the most horrible’ affects both physiological and psychological aspects of labour. Thus, the provision of labour analgesia is of paramount importance to better both maternal and neonatal outcomes. In our country, majority of obstetric services are in the hands of trained nurses and non-specialized doctors and thus awareness and acceptance of pain-relieving for women in labour virtually does not exist. Therefore, drugs like paracetamol and tramadol with advantage of easy availability, being inexpensive with no special technique of administration are a boon for labour analgesia. Objective: To compare the role of intravenous paracetamol versus intravenous tramadol as an intrapartum labour analgesic. Materials and methods: A total of 273 primigravidae with term gestation with singleton pregnancy with vertex presentation in active phase of labour with cervical dilatation ≥ 4cm with spontaneous onset of labour were taken who satisfied the inclusion and exclusion criteria of the study. Group P (141 women) and Group T (132 women) received 100 ml intravenous infusion containing 1 gram of paracetamol single dose and 100 mg of tramadol hydrochloride diluted in 100 ml normal saline over 15 minutes respectively. Visual Analogue scale (VAS) was used to assess pain intensity, before administering drug, after 1 and 3 hours of drug administration. The primary outcomes measured were difference in VAS score in both groups. The secondary outcomes analysed were mode of delivery, duration of labour, drug-delivery interval, maternal side effects and neonatal outcomes in terms of birth weight, APGAR scores and NICU admissions. Results: The mean VAS score decreased significantly to a greater extent in group P than group T and showed a significant statistical difference among both the groups (p < 0.001). In both the groups, the difference in the VAS score was statistically significant (p<0.05). The duration of labour was statistically shorter in group P (p< 0.0001). The participants in group T had more incidence of maternal side-effects and 7 NICU admission than in paracetamol group. Conclusion: Intravenous paracetamol with better analgesic efficacy, shorter duration of labour and fewer maternal side effects is a more effective labour analgesic than tramadol.