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

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.

Description

Eligibility

Age range

16–50 years

Sex

Female

Healthy volunteers

No

Interventions

• Drug
  Acetaminophen 1000mg PO

  Oral Acetaminophen 1000mg

• Drug
  IV Acetaminophen 1000mg

  Intravenous Acetaminophen 1000mg

• Other
  IV Placebo

  IV placebo administration

• Other
  PO Placebo

  Oral placebo administration

Location