Two prophylactic pain management regimens for medical abortion ≤63 days' gestation with mifepristone and misoprostol: A multicenter, randomized, placebo-controlled trial
| Autor: | Jean-Louis Yoko, Jageshwor Gautam, Nathalie Kapp, My Huong Nguyen, Tshego Bessenaar, Anand Tamang, Daniel Grossman, Lan Dung Duong, Metin Gülmezoglu, Monica Dragoman, Ndema Habib, Minh Hong |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Metoclopramide
medicine.medical_treatment Placebo-controlled study Pain Abortion Placebo 03 medical and health sciences 0302 clinical medicine Pregnancy medicine Humans Pain Management 030212 general & internal medicine Misoprostol Abortifacient Agents Nonsteroidal 030219 obstetrics & reproductive medicine business.industry Obstetrics and Gynecology Abortion Induced Ibuprofen Medical abortion Mifepristone Reproductive Medicine Anesthesia Female Tramadol business medicine.drug |
| Zdroj: | Contraception. 103(3) |
| ISSN: | 1879-0518 |
| Popis: | 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.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.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 = 0.0001). 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 (p0.001) 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).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.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. |
| Databáze: | OpenAIRE |
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