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Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain
Sponsor: Montefiore Medical Center
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.
Official title: Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)
Key Details
Gender
FEMALE
Age Range
16 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-11
Completion Date
2027-10
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Acetaminophen 1000mg PO
Oral Acetaminophen 1000mg
IV Acetaminophen 1000mg
Intravenous Acetaminophen 1000mg
IV Placebo
IV placebo administration
PO Placebo
Oral placebo administration
Locations (1)
Montefiore Medical Center
The Bronx, New York, United States