Intravenous vs Oral Acetaminophen for Pelvic Pain

(PIVOTAL Trial)

Overseen By Mustfa Manzur, MD MPH MS

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must not be taking: Analgesics, Acetaminophen

Disqualifiers: Acetaminophen allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Eddie M Irizarry, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who were born female, have come to the emergency department with pelvic pain rated at least 4 out of 10, and can give consent in English or Spanish.

Inclusion Criteria

Ability to provide informed consent in English or Spanish

I was assigned female at birth.

My pain level is 4 or higher on a 0-10 scale.

Exclusion Criteria

Known allergy or intolerance to acetaminophen

I have taken pain medication in the last 2 hours or acetaminophen in the last 6 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either intravenous or oral acetaminophen to assess pain improvement

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen

Trial Overview

The study compares how well acetaminophen (Tylenol) works for pelvic pain when given by mouth versus through an IV. Participants are randomly assigned to receive either form along with a placebo so neither they nor doctors know which one they're getting.

How Is the Trial Designed?

Group I: Intravenous Drug + Oral Placebo Active Control 2 Interventions

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.

Group II: Oral Drug + IV Placebo Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+