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

NCT07595302 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

DRUG

IV Acetaminophen 1000mg

Intravenous Acetaminophen 1000mg

OTHER

IV Placebo

IV placebo administration

OTHER

PO Placebo

Oral placebo administration

DRUG

Acetaminophen 1000mg PO

Oral Acetaminophen 1000mg

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Eddie M Irizarry, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595302 on ClinicalTrials.gov