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

Study acronym: PIVOTAL
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 30, 2027 → Oct 2027
See other at-risk trials from Montefiore Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Jul 30, 2026 to Nov 2026 Show 4 more changesShow less
    • Primary and study completion pushed from Jun 30, 2027 to Oct 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Publications: details revised at 15 of 15 entries
  2. Study description shortened, about 69 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07595302
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Pelvic Pain
Related terms Pelvic Pain
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov