๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-18

Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain (NCT07595302)

Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)

๐ŸŸก Not Yet Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Montefiore Medical Center

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Montefiore Medical Center โ€” The Bronx, New York

Age range: 16 Years to 50 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Montefiore Medical Center โ€” The Bronx, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (718) 920-6674

Email: mmanzur@montefiore.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—