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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT07595302
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Pelvic Pain

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Acetaminophen 1000mg PO — DRUG
    Oral Acetaminophen 1000mg
  • IV Acetaminophen 1000mg — DRUG
    Intravenous Acetaminophen 1000mg
  • IV Placebo — OTHER
    IV placebo administration
  • PO Placebo — OTHER
    Oral placebo administration

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
Nov 30, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral Drug + IV Placebo
    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.
  • Active Comparator: Intravenous Drug + Oral Placebo
    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.

Primary Outcome Measure

Mean Change in Numeric Rating Scale (NRS) score [ Time Frame: From baseline to 30 minutes following medication administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10467
Mustfa Manzur, MD MPH MS
[email protected]
718-920-6626
Eddie M Irizarry, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Montefiore Medical Center· The Bronx, NY

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