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

ConditionPelvic Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age16-50
SponsorMontefiore Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours

Known allergy or intolerance to acetaminophen

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetaminophen 1000mg PO

    Drug

    Oral Acetaminophen 1000mg

  • IV Acetaminophen 1000mg

    Drug

    Intravenous Acetaminophen 1000mg

  • IV Placebo

    Other intervention

    IV placebo administration

  • PO Placebo

    Other intervention

    Oral placebo administration

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Oral Drug + IV PlaceboActive comparator 2 interventions
Group B: Intravenous Drug + Oral PlaceboActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Mean Change in Numeric Rating Scale (NRS) score

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.

Time frame
From baseline to 30 minutes following medication administration

Secondary outcomes

1

Pain Intensity

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.

Time frame
0-, 5-, 10-, 15-, 30-, 45-, 60- and 120-minutes following medication administration
2

Time to Clinically Meaningful Reduction in Pain

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.

Time frame
Within 2 hours after medication administration
3

Use of Rescue Medications

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

Time frame
Within 2 hours following medication administration
4

Patient Global Impression of Change (PGI-C) Score

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.

Time frame
30- and 120-minutes following medication administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montefiore Medical Center

Lead sponsor

Source ClinicalTrials.gov

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