Two prophylactic pain management regimens for medical abortion ≤63 days' gestation with mifepristone and misoprostol: A multicenter, randomized, placebo-controlled trial

Abstract

Objective: To determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion. Study design: We conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction. Results: We enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0 0 01). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness ( p = 0.004), headache ( p = 0.03), and vomiting ( p < 0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group ( p = 0.05); overall abortion satisfaction did not differ by group ( p = 0.44). Conclusions: Compared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects. Implications: Given that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion.

Adherence to treatment and prevalence of side effects when medical abortion is delivered via telemedicine: a prospective observational cohort study during COVID-19

“…We were only able to offer a single antiemetic in the form of oral cyclizine during this study. There may be other antiemetics that are better suited to managing nausea during medical abortion, such as metoclopramide, 24 but further study is required.…”

Comparison of misoprostol and manual vacuum aspiration in treating first-trimester incomplete miscarriage: a systematic review and meta-analysis of randomized controlled trials

“…Therefore, intake of ibuprofen (600 mg) 1 hour before the use of misoprostol could be helpful in reducing both fever and abdominal pain [28] . Previous reports also indicated that ibuprofen (600 mg) could be taken every eight hours in severe cases to avoid high temperature and abdominal pain [29][30][31] . In addition, since misoprostol was a prostaglandin E1 analogue, it might have bene ts in relieving gastric or duodenal ulcers [32,33] .…”

Efficacy of Ibuprofen Lysine on First-Trimester AbortionRelated Pain and Hemorrhage: A Randomized TripleBlinded Clinical Trial

“… 11 , 12 Although supplemental narcotics have limited value, they may be also prescribed. 13 Various painkillers are used to relieve post-abortion pain, the most important of which are opioids. Although opioids are very effective in controlling abortion-related pain, because of their side effects such as drowsiness, nausea and vomiting, ileus, constipation, respiratory suppression, central nervous system inhibition and even addiction, researchers try to identify other analgesic medications with acceptable efficacy along with higher safety.…”