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

NCT07595302 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025-17368
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Pain

Keywords

pregnancy; acetaminophen; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean Change in Numeric Rating Scale (NRS) score

  Mean Change in NRS score will be assessed at 30 minutes post-treatment. The NRS is a patient self-assessment pain scale that instructs patients to use a facial grimace scale ranging from 0-10 rating to express pain intensity, wherein 0 is "No pain" and 10 is "Worst pain possible," such that higher scores are indicative of greater pain intensity. For purposes of the primary outcome change in NRS score from baseline will be assessed. Results will be summarized by study arm using descriptive statistics.

  From baseline to 30 minutes following medication administration

Secondary Outcomes (8)

• Pain Intensity

  0-, 5-, 10-, 15-, 30-, 45-, 60- and 120-minutes following medication administration

• Time to Clinically Meaningful Reduction in Pain

  Within 2 hours after medication administration

• Use of Rescue Medications

  Within 2 hours following medication administration

• Patient Global Impression of Change (PGI-C) Score

  30- and 120-minutes following medication administration

• Treatment-Related Adverse Events (TRAEs)

  Within 2 hours following medication administration

Study Arms (2)

Oral Drug + IV Placebo

ACTIVE COMPARATOR

Oral Acetaminophen 1000mg + IV placebo Oral Acetaminophen 1000mg No additional analgesics will be administered prior to two hours unless clinically indicated. Rescue analgesia may be administered at any time at the discretion of the treating clinician.

Drug: Acetaminophen 1000mg PO; Other: IV Placebo

Intravenous Drug + Oral Placebo

ACTIVE COMPARATOR

Intravenous Acetaminophen + PO placebo IV Acetaminophen 1000mg No additional analgesics will be administered prior to two hours unless clinically indicated. Rescue analgesia may be administered at any time at the discretion of the treating clinician.

Drug: IV Acetaminophen 1000mg; Other: PO Placebo

Interventions

Acetaminophen 1000mg PO DRUG

Oral Acetaminophen 1000mg

Oral Drug + IV Placebo

IV Acetaminophen 1000mg DRUG

Intravenous Acetaminophen 1000mg

Intravenous Drug + Oral Placebo

IV Placebo OTHER

IV placebo administration

Oral Drug + IV Placebo

PO Placebo OTHER

Oral placebo administration

Intravenous Drug + Oral Placebo

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female sex at birth
• Presentation to the Emergency Department (ED) with pelvic pain
• Baseline numeric pain score (NRS) ≥4
• Ability to provide informed consent in English or Spanish

You may not qualify if:

• Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours
• Known allergy or intolerance to acetaminophen

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (15)

• 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.

  PMID: 28742676 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.

  PMID: 28993061 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.

  PMID: 38905718 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.

  PMID: 15790675 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.

  PMID: 22524979 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.

  PMID: 3204515 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.

  PMID: 24084542 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.

  PMID: 26448875 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.

  PMID: 12919986 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.

  PMID: 16824213 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.

  PMID: 36465795 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.

  PMID: 28276273 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.

  PMID: 11992334 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.

  PMID: 16689556 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.

  PMID: 22299823 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Eddie M Irizarry, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustfa Manzur, MD MPH MS

CONTACT

718-920-6674; mmanzur@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation concealment will be maintained using sequentially numbered medication kits prepared by the research pharmacy. Participants, treating clinicians, research staff, outcome assessors, and investigators will remain blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio. Randomization will be performed using a computer-generated block randomization scheme, stratified by study site.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)