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Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain (PIVOTAL)

18. mai 2026 oppdatert av: Montefiore Medical Center

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

140

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • New York
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Eddie M Irizarry, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Oral Drug + IV Placebo

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.
Legemiddel: Acetaminophen 1000mg PO
Oral Acetaminophen 1000mg
Annen: IV Placebo
IV placebo administration
Aktiv komparator: Intravenous Drug + Oral Placebo

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.
Legemiddel: IV Acetaminophen 1000mg
Intravenous Acetaminophen 1000mg
Annen: PO Placebo
Oral placebo administration

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change in Numeric Rating Scale (NRS) score
Tidsramme: 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.
From baseline to 30 minutes following medication administration

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Intensity
Tidsramme: 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.
0-, 5-, 10-, 15-, 30-, 45-, 60- and 120-minutes following medication administration
Time to Clinically Meaningful Reduction in Pain
Tidsramme: 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.
Within 2 hours after medication administration
Use of Rescue Medications
Tidsramme: 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.
Within 2 hours following medication administration
Patient Global Impression of Change (PGI-C) Score
Tidsramme: 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.
30- and 120-minutes following medication administration
Treatment-Related Adverse Events (TRAEs)
Tidsramme: 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.
Within 2 hours following medication administration
Emergency Department (ED) Disposition
Tidsramme: 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.
At 2 hours following medication administration
Length of Stay (LOS)
Tidsramme: 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.
Less than 24 hours following medication administration
Patient Satisfaction
Tidsramme: 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.
At 2 hours following medication administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Montefiore Medical Center

Etterforskere

  • Hovedetterforsker: Eddie M Irizarry, MD, Montefiore Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. juli 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

19. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-17368

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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