Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)
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.
Description
An estimated 70% of Emergency Department (ED) visits involve pain as a complaint. Although ED practice has shifted away from routine opioid prescribing, uncertainty remains regarding optimal selection among commonly used non-opioid analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. Medication selection varies by pain etiology, and among patients presenting with musculoskeletal pain, opioids (40.7%), acetaminophen (37.8%), and NSAIDs (22.6%) remain the most frequently administered medications in the ED. Pain in women has been comparatively understudied. Pelvic…
Eligibility
- Age range
- 16–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female sex at birth * Presentation to the Emergency Department (ED) with pelvic pain * Baseline numeric pain score (NRS) ≥4 * Ability to provide informed consent in English or Spanish Exclusion Criteria: * Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours * Known allergy or intolerance to acetaminophen
Interventions
- DrugAcetaminophen 1000mg PO
Oral Acetaminophen 1000mg
- DrugIV Acetaminophen 1000mg
Intravenous Acetaminophen 1000mg
- OtherIV Placebo
IV placebo administration
- OtherPO Placebo
Oral placebo administration
Location
- Montefiore Medical CenterThe Bronx, New York