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NCT Number: NCT07595302

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

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.

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Key information

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location contact

Eddie M Irizarry, MD

PRINCIPAL_INVESTIGATOR

Mustfa Manzur, MD MPH MS

CONTACT

[email protected]

718-920-6626

About this study

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 pain is common among women of childbearing age, and chronic pelvic pain affects up to 24% of women overall. In nonpregnant women, NSAIDs are widely considered first-line therapy for both acute and chronic pelvic pain. In pregnant women and in those attempting to conceive, NSAIDs are typically avoided. Observational studies have associated NSAID use around the time of conception or prior to 20 weeks' gestation with an increased risk of miscarriage, while acetaminophen has not shown a similar association. NSAID exposure in early pregnancy has also been linked to congenital anomalies.

Guidelines recommend limiting opioid use during pregnancy and in women of childbearing age. Opioid exposure has been associated with congenital anomalies and with poorer maternal and neonatal outcomes. As a result, opioids are generally avoided as first-line therapy for pelvic pain in patients who are pregnant or may be pregnant.

Therefore, it is routine to ascertain pregnancy status prior to administering NSAIDs or opioids to women of childbearing age for an informed decision making discussion. Acetaminophen, in contrast, is generally considered safe in pregnancy and can be administered without delay while awaiting pregnancy testing. Acetaminophen is associated with relatively mild side effects, which may vary by route of administration.

Pharmacokinetic studies demonstrate that intravenous acetaminophen achieves higher peak plasma concentrations and faster central nervous system penetration than oral administration. Outside the ED, IV acetaminophen has been associated with faster onset of meaningful pain relief and reduced opioid use in some surgical populations. Whether these pharmacologic advantages translate into clinically meaningful improvements in acute pelvic pain management in the Emergency Department for patients of childbearing potential with pelvic pain is unclear.

The investigator team hypothesizes that among women aged 16-50 presenting to the emergency department with pelvic pain, patients receiving intravenous acetaminophen will achieve a greater improvement in the numeric rating scale (NRS) pain score at 30 minutes compared with oral acetaminophen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Mean Change in Numeric Rating Scale (NRS) score

    Time frame: From baseline to 30 minutes following medication administration

    Mean Change in NRS score will be assessed at 30 minutes post-treatment. The NRS is a patient self-assessment pain scale that instructs patients to use a facial grimace scale ranging from 0-10 rating to express pain intensity, wherein 0 is "No pain" and 10 is "Worst pain possible," such that higher scores are indicative of greater pain intensity. For purposes of the primary outcome change in NRS score from baseline will be assessed. Results will be summarized by study arm using descriptive statistics.

Secondary outcomes

  1. Pain Intensity

    Time frame: 0-, 5-, 10-, 15-, 30-, 45-, 60- and 120-minutes following medication administration

    Participants will be asked to serially assess their current level of pain intensity as either "Severe," "Moderate," "Mild," or "None." Categorical assessments of pain intensity will be summarized by study arm at each prespecified timepoint.

  2. Time to Clinically Meaningful Reduction in Pain

    Time frame: Within 2 hours after medication administration

    Time to clinically meaningful pain reduction as assessed by the Numerical Rating Scale (NRS). The NRS is a pain scale that uses a 0-10 rating to measure pain intensity, where 0 is "No pain" and 10 is "Worst pain possible." Clinically meaningful pain reduction will be defined as achieving a reduction in NRS score of ≥1.3 from baseline. Results will be summarized by study arm using basic descriptive statistics.

  3. Use of Rescue Medications

    Time frame: Within 2 hours following medication administration

    The number/percentage of patients requiring rescue analgesia of any type within 120 minutes will be summarized by study arm using basic descriptive statistics.

  4. Patient Global Impression of Change (PGI-C) Score

    Time frame: 30- and 120-minutes following medication administration

    Effectiveness of treatment will be evaluated using the PGI-C scale. The PGI-C scale is a 7-point self-reported scale used to assess the patient's perception of change in condition/health status following treatment. Patients will provide a single response as to their self-perception of change in condition/health status on a scale ranging from 1 ("Very much improved") to 7 ("Very much worse)" with 4 representing "No change" as the midpoint. Lower scores are indicative of an improved self-assessment of condition following treatment. Scores will be summarized by study arm using descriptive statistics.

  5. Treatment-Related Adverse Events (TRAEs)

    Time frame: Within 2 hours following medication administration

    All treatment-related adverse events occurring within 2 hours of medication administration will be recorded and summarized by study arm.

  6. Emergency Department (ED) Disposition

    Time frame: At 2 hours following medication administration

    ED disposition will be summarized at 2 hours. Patients will be categorized as either having been admitted, discharged, or status yet to be determined. Categorical data will be summarized by study arm.

  7. Length of Stay (LOS)

    Time frame: Less than 24 hours following medication administration

    Length of stay will be determined based on the time interval between arrival in the ED and disposition determination. Mean LOS will be summarized by study arm.

  8. Patient Satisfaction

    Time frame: At 2 hours following medication administration

    Patient satisfaction will be determined by asking patients whether they would prefer the same medication which was administered during the study if they returned to the ED with the same condition. The number/percentage of patients who prefer the same medication will be summarized by study arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Mustfa Manzur, MD MPH MS

CONTACT

[email protected]

718-920-6674

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Acronym: PIVOTAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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