AIM: To evaluate the efficacy and adverse effects of an i.v. infusion of paracetamol during the active phase of labor as compared with sterile water (placebo) as a method for intrapartum analgesia. METHODS: In a triple-blind, randomized, placebo-controlled trial, 120 low-risk primiparous women presenting in active labor at Ain Shams University Maternity Hospital, Cairo, Egypt, between August 2011 and October 2012, were allocated to receive either 1000 mg i.v. of paracetamol (n = 60) or sterile water (n = 60). The primary outcomes were the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale (VAS) pain intensity score at various time points after drug administration and the need for additional rescue analgesia. The secondary outcomes included the presence of adverse maternal or fetal events. RESULTS: Compared to controls, i.v. infusion of paracetamol was associated with significantly lower VAS score 15 and 30 min after the start of medication; also, there was a significantly lower incidence of need for rescue medication (8/57 [14%] vs 49/59 [83.1%], P < 0.001) at 60 min after the start of medication. There were no recorded maternal adverse effects in either group. There were no differences in occurrence of intrapartum fetal distress or neonatal Apgar scores between both groups. CONCLUSION:Paracetamol appears to be a safe and effective medicine that can be used during the intrapartum period.
RCT Entities:
AIM: To evaluate the efficacy and adverse effects of an i.v. infusion of paracetamol during the active phase of labor as compared with sterile water (placebo) as a method for intrapartum analgesia. METHODS: In a triple-blind, randomized, placebo-controlled trial, 120 low-risk primiparous women presenting in active labor at Ain Shams University Maternity Hospital, Cairo, Egypt, between August 2011 and October 2012, were allocated to receive either 1000 mg i.v. of paracetamol (n = 60) or sterile water (n = 60). The primary outcomes were the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale (VAS) pain intensity score at various time points after drug administration and the need for additional rescue analgesia. The secondary outcomes included the presence of adverse maternal or fetal events. RESULTS: Compared to controls, i.v. infusion of paracetamol was associated with significantly lower VAS score 15 and 30 min after the start of medication; also, there was a significantly lower incidence of need for rescue medication (8/57 [14%] vs 49/59 [83.1%], P < 0.001) at 60 min after the start of medication. There were no recorded maternal adverse effects in either group. There were no differences in occurrence of intrapartum fetal distress or neonatal Apgar scores between both groups. CONCLUSION:Paracetamol appears to be a safe and effective medicine that can be used during the intrapartum period.