Paracetamol versus ibuprofen for early postpartum pain control: a randomized controlled trial

Archives of Gynecology and Obstetrics https://doi.org/10.1007/s00404-024-07797-4 MATERNAL-FETAL MEDICINE Paracetamol versus ibuprofen for early postpartum pain control: a randomized controlled trial Shai Ram1 · Dotan Madar1 · Hila Shalev Ram3,4 · Goni Peleg1 · Yotam Lior2 · Ayelet Greenfeld1 · Gala Yakov1 · Yariv Yogev1 · Sharon Maslovitz1 Received: 8 August 2024 / Accepted: 13 October 2024 © The Author(s) 2024 Abstract Introduction To evaluate the effectiveness of paracetamol and ibuprofen as non-opioid treatments for postpartum pain control after vaginal delivery. Materials and methods This randomized controlled study at a university-affiliated medical center involved parturient who received blindly oral tablets of either 1000 mg of paracetamol or 400 mg of ibuprofen, post-vaginal birth. Pain levels were assessed using a numeric rating scale (NRS) at four time points: before treatment, and 1, 4, and 6 h post-treatment (T0, T1, T4, and T6, respectively). We also compared the need for additional analgesia, breastfeeding initiation, mobilization, and urination following the delivery between the groups. To ensure statistical power, the study was designed to detect differences of one point on the NRS with at least 37 women per group. Results A total of 107 women participated, including paracetamol (n = 52) and ibuprofen (n = 55) groups. Demographics and perinatal outcomes were similar across groups. No significant differences were found in the interval between delivery and request for pain control (8 ± 6–10.5 and 11 ± 6–16 h for the paracetamol and the ibuprofen, respectively, P = .13). Pain levels on the NRS were similar for both groups at all intervals. There were also no group differences in the time to the initiation of breastfeeding, mobilization, urination, or the need for additional analgesia. Conclusion Both, paracetamol and ibuprofen, can be considered equivalent and effective non-opioid alternatives for postpartum pain control. Registry at clinicaltrials.gov (NCT04653506), https://register.clinicaltrials.gov/prs/beta/studies/S000AFOR00000066/recor dSummary. Keywords Postpartum pain · Non-opioid treatments · Ibuprofen · Paracetamol · Pain relief strategies after vaginal delivery What does this study add to the clinical work Paracetamol and ibuprofen provide comparable immediate postpartum analgesia, presenting possible non-opioid alternative for pain management. * Shai Ram 1 Lis Maternity and Women’s Hospital, 6 Weitzman St, 6423906 Tel Aviv, Israel 2 Division of Anesthesia, Intensive Care, and Pain Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel 3 Department of Obstetrics and Gynecology, Meir Medical Center, Kfar Saba, Israel 4 Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Introduction Postpartum pain is common, with 75–97% of women reporting perineal pain within one day of giving birth, and as high as 90% of those women reporting that the pain impedes their ability to carry out daily activities and care for their newborns [1]. Uncontrolled postpartum pain has been associated with significant adverse outcomes, such as difficulties in emotion regulation, maternal depression, chronic pain, and increased reliance upon opioid medications [2–5]. Approximately 1.7% of women who underwent vaginal delivery and 2.2% of those who underwent a cesarean section reportedly developed a persistent pattern of opioid usage [3]. Longterm use of opioid medications is associated with several disadvantages, including substance dependency [15] and breastfeeding that can be affected by the transfer of opioids through breastfeeding [6], potentially leading to undesirable Vol.:(0123456789) Archives of Gynecology and Obstetrics effects on the newborn, such as drowsiness. These concerns have led to the search for equally effective non-opioid strategies for postpartum pain relief to replace opioid use and enhance recovery [1, 7, 8]. While numerous analgesic regimens are commonly practiced in the clinical setting, scientific literature on comparisons of their efficacy is lacking. Paracetamol and members of the NSAIDs family, such as ibuprofen, are among those agents used in common practice. A systematic Cochrane meta-analysis [9] assessed the efficacy of paracetamol treatment compared with placebo for perineal pain relief after childbirth. Although the studies included in the review found paracetamol to be more effective than placebo in alleviating pain, another study [10] demonstrated the superiority of non-steroidal anti-inflammatory drugs (NSAIDs) over a placebo in relieving pain following vaginal delivery. However, there was no significant difference between treatment nor any significant difference in pain relief originating from immediate postpartum uterine contractions between paracetamol and placebo. These findings are also supported by a meta-analysis [9]. The conclusions that were reached in that review, however, were based upon a single study with a small sample size (48 cases). A Cochrane metanalysis [11] indicated that NSAIDs were more effective than placebo for perineal pain relief after vaginal delivery at both 4 and 6 h after administration, although the quality of the evidence was considered to be low. Additionally, that meta-analysis found that NSAIDs were more effective than paracetamol at 4 h but not significantly different at 6 h. As in earlier meta-analyses, the studies included in that review were outdated, and the authors acknowledged potential biases in the results, highlighting the need for updated nonbiased studies. It has not been established which non-opioid interventions are effective for specific types or locations of pain (e.g., perineal pain, uterine contractions, back pain), nor have the factors of general reduction of postpartum pain, the time interval between childbirth and the need for pain relief, and the potential impact of pain control on breastfeeding ability. Thus, we aimed to compare single administration of nonopioid medications, specifically paracetamol (1000 mg) and ibuprofen (400 mg) in terms of their effectiveness in relieving general postpartum pain across different time frames. We also aimed to assess the association between postpartum pain relief with the time to the initiation of breastfeeding, mobility and spontaneous urination, and the need for additional pain relief. Materials and methods We conducted a double-blind, randomized controlled interventional study at a single university-affiliated medical center. This study was approved by the local Institutional Review Board (IRB number 036820-TLV) and registered at clinicaltrials.gov NCT04653506. The study started on 22/11/2020 and ended on 18/02/2024. The study included a cohort of consecutive women who underwent spontaneous vaginal delivery between February 2021 and June 2022 and provided informed consent to participate. Excluded were women who had undergone a caesarean section, had a known sensitivity to any of the study medications, were classi (...truncated)