Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain

Summary

The investigator team proposes a randomized, double-blind, double-dummy comparative effectiveness trial conducted in two urban emergency departments (EDs) in the Bronx, New York. This study is designed to determine the relative efficacy of IV acetaminophen compared to PO acetaminophen in treating pelvic pain. This design focuses on the early onset of action and short-term efficacy, which may better capture potential differences between IV and PO acetaminophen in the acute ED setting.

Timeline

Start

2026-07-30

Primary completion

2027-06-30

Completion

2027-06-30

Publications

• Background Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
• Background Interrante JD, Ailes EC, Lind JN, Anderka M, Feldkamp ML, Werler MM, Taylor LG, Trinidad J, Gilboa SM, Broussard CS; National Birth Defects Prevention Study. Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011. Ann Epidemiol. 2017 Oct;27(10):645-653.e2. doi: 10.1016/j.annepidem.2017.09.003. Epub 2017 Sep 20.
• Background Gottlieb M, Bernard K. Epidemiology of back pain visits and medication usage among United States emergency departments from 2016 to 2023. Am J Emerg Med. 2024 Aug;82:125-129. doi: 10.1016/j.ajem.2024.06.020. Epub 2024 Jun 15.
• Background Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
• Background Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
• Background van Bree JB, de Boer AG, Danhof M, Ginsel LA, Breimer DD. Characterization of an "in vitro" blood-brain barrier: effects of molecular size and lipophilicity on cerebrovascular endothelial transport rates of drugs. J Pharmacol Exp Ther. 1988 Dec;247(3):1233-9.
• Background Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol. 2013 Oct;122(4):838-844. doi: 10.1097/AOG.0b013e3182a6643c.
• Background Shah S, Banh ET, Koury K, Bhatia G, Nandi R, Gulur P. Pain Management in Pregnancy: Multimodal Approaches. Pain Res Treat. 2015;2015:987483. doi: 10.1155/2015/987483. Epub 2015 Sep 13.
• Background Li DK, Liu L, Odouli R. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. BMJ. 2003 Aug 16;327(7411):368. doi: 10.1136/bmj.327.7411.368.
• Background Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.
• Background Juganavar A, Joshi KS. Chronic Pelvic Pain: A Comprehensive Review. Cureus. 2022 Oct 26;14(10):e30691. doi: 10.7759/cureus.30691. eCollection 2022 Oct.
• Background Hansen RN, Pham AT, Boing EA, Lovelace B, Wan GJ, Miller TE. Comparative analysis of length of stay, hospitalization costs, opioid use, and discharge status among spine surgery patients with postoperative pain management including intravenous versus oral acetaminophen. Curr Med Res Opin. 2017 May;33(5):943-948. doi: 10.1080/03007995.2017.1297702. Epub 2017 Mar 9.
• Background Cordell WH, Keene KK, Giles BK, Jones JB, Jones JH, Brizendine EJ. The high prevalence of pain in emergency medical care. Am J Emerg Med. 2002 May;20(3):165-9. doi: 10.1053/ajem.2002.32643.
• Background Boubred F, Vendemmia M, Garcia-Meric P, Buffat C, Millet V, Simeoni U. Effects of maternally administered drugs on the fetal and neonatal kidney. Drug Saf. 2006;29(5):397-419. doi: 10.2165/00002018-200629050-00004.
• Background Antonucci R, Zaffanello M, Puxeddu E, Porcella A, Cuzzolin L, Pilloni MD, Fanos V. Use of non-steroidal anti-inflammatory drugs in pregnancy: impact on the fetus and newborn. Curr Drug Metab. 2012 May 1;13(4):474-90. doi: 10.2174/138920012800166607.

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Indications