Fixed-Time Interval vs. On-Demand Oral Analgesia Following Vaginal Delivery: A Randomized Controlled Trial.

BACKGROUND: Scheduled administration of analgesics was proven superior to on-demand dosing following cesarean deliveries. However, this protocol was not compared after vaginal delivery.

OBJECTIVE: To compare the efficacy of a fixed- compared to on-demand analgesic protocol for the management of pain in the first 24 hours after a vaginal delivery.

STUDY DESIGN: This randomized, prospective, controlled trial was conducted at a single tertiary medical center, between June 1, 2020, and June 30, 2022. Vaginally delivered patients were randomly assigned to receive oral analgesics (paracetamol 1 g + ibuprofen 400 mg) either every 6 h for the first 24 hours postpartum (scheduled analgesia group) or as needed (on-demand group). Pain level during the first 24 hours post-delivery was measured using a 10-point visual analog scale (VAS).

RESULTS: A total of 200 patients were randomized 1:1 to the two cohorts. Baseline and delivery characteristics, including oxytocin augmentation, epidural anesthesia, episiotomy rate and neonatal birthweight, were comparable between groups. Patients in the scheduled group received more paracetamol and ibuprofen doses in the first 24 hours (2.9±1.3 and 2.9±1.2 doses vs. 0.8±1.1 and 0.7±1.1 doses, respectively, p<0.001)). Pain score was comparable between study groups (5.31±1.92 vs. 5.29±1.67, p=0.626) even following sub-analysis for primiparity, episiotomy and vacuum-assisted delivery (p>0.05). However, patients on a fixed treatment schedule were more likely to breastfeed their baby (98% vs. 88%, p=0.006) as compared to those receiving treatment on demand. In addition, they were more satisfied with their labor and delivery experience, as evaluated by BSS-R questionnaires quality control (QC; 37.9±4.7 vs. 31.1±5.2; p=0.0324), patient attributes (WA; 35±5.1 vs. 30.3±6.3, p=0.0453), and stress experienced (SE; 58.1±8.5 vs. 50.1±8.3, p=0.0398). No side effects or adverse outcomes were reported in either group.

CONCLUSION: A scheduled analgesic protocol for postpartum pain management following vaginal delivery revealed similar pain scores compared with an on-demand protocol, although it was associated with higher breastfeeding rates and higher maternal satisfaction.