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Paracetamol prior to catheter balloon insertion for labor induction-A randomized controlled trial
Maya Frank Wolf1, Inshirah Sgayer1, Raneen Abu Shqara1
1Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel (Wolf, Sgayer, Shqara, Naskovica, Kassis, Kushnir, Lavinsky, Idilbi, Lowenstein); Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel (Wolf, Sgayer, Shqara, Naskovica, Lowenstein).
Background:
Assessing maternal pain and satisfaction following administration of paracetamol vs. placebo prior to catheter balloon placement.
Methods:
Primiparous women at term admitted for medically-indicated labor induction were randomized to receive intravenous paracetamol 1 gram in 100cc normal saline (N=71) or placebo of 100cc normal saline (N=70) prior to catheter balloon insertion. The women were blinded to the intervention allocation. Primary outcomes were visual analog scale (VAS) scores and maternal satisfaction, assessed via questionnaire.
Results:
Pre-induction maternal pain did not differ between the paracetamol and placebo groups. Median VAS scores at 2, 30, and 60 minutes after catheter insertion were comparable between the groups: 6.46±2.77 vs. 6.66±2.78, P=.68; 5.53±3.20 vs. 5.93±3.01, P=.46; and 5.83±3.25 vs. 6.49±2.88, P=.26, respectively. For the paracetamol vs. placebo group, the mean sum of VAS scores was lower (4.39 vs. 5.37, P=.045) and the proportion with a mean VAS score <5 was higher (65.2% vs. 44.1%, P=.016). This difference persisted in a multivariate logistic regression analysis adjusted for maternal age (OR=2.2, 95% CI 1.1-4.5, P=.036). After balloon insertion, relatively fewer women in the paracetamol vs. placebo group showed immobility (33.8% vs 50.0%, P=.037) and needed analgesics (31.3% vs. 66.1%, P<.001). Maternal satisfaction score was similar between the groups (P=.877). Cervical ripening, duration from catheter insertion to delivery, and labor and neonatal outcomes did not differ significantly between the groups.
Conclusions:
The administration of paracetamol compared with placebo prior to catheter balloon insertion was associated with lower VAS score and less analgesic use and maternal immobility. El resumen está disponible en Español al final del artículo.
