Pelvic PainPhase 4PIVOTALNCT07595302
Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain
A Phase 4 study testing Acetaminophen 1000mg PO and IV Acetaminophen 1000mg in people with Pelvic Pain, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Acetaminophen 1000mg PO and IV Acetaminophen 1000mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours
- Known allergy or intolerance to acetaminophen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
Mustfa Manzur, MD MPH MS, 718-920-6626, mmanzur@montefiore.org
Eddie M Irizarry, MD
About this study
Official title: 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.
Read the detailed 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 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.
- Conditions
- Pelvic Pain
- Being tested
- Acetaminophen 1000mg PO, IV Acetaminophen 1000mg, IV Placebo, PO Placebo
- Keywords
- pregnancy, acetaminophen, randomized controlled trial
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 1000mg PODrug
Oral Acetaminophen 1000mg
IV Acetaminophen 1000mgDrug
Intravenous Acetaminophen 1000mg
IV PlaceboOther
IV placebo administration
PO PlaceboOther
Oral placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Oral Drug + IV Placebo | Active comparator | 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. Receives: Drug: Acetaminophen 1000mg PO; Other: IV Placebo |
| Intravenous Drug + Oral Placebo | Active comparator | 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. Receives: Drug: IV Acetaminophen 1000mg; Other: PO Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 30 minutes following medication administration
Secondary outcomes (8)
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.
Measured: 0-, 5-, 10-, 15-, 30-, 45-, 60- and 120-minutes following medication administration
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.
Measured: Within 2 hours after medication administration
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.
Measured: Within 2 hours following medication administration
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.
Measured: 30- and 120-minutes following medication administration
Treatment-Related Adverse Events (TRAEs)
All treatment-related adverse events occurring within 2 hours of medication administration will be recorded and summarized by study arm.
Measured: Within 2 hours following medication administration
Emergency Department (ED) Disposition
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.
Measured: At 2 hours following medication administration
Length of Stay (LOS)
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.
Measured: Less than 24 hours following medication administration
Patient Satisfaction
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.
Measured: At 2 hours following medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio. Randomization will be performed using a computer-generated block randomization scheme, stratified by study site.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eddie M Irizarry, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595302
- Sponsor's protocol ID
- 2025-17368
- Other IDs
- 2025
- Acronym
- PIVOTAL
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
PubMed 28742676Interrante JD, Ailes EC, Lind JN, Anderka M, Feldkamp ML, Werler MM, Taylor LG, Trinidad J, Gilboa SM, Broussard CS; National Birth Defects Prevention Study. Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011. Ann Epidemiol. 2017 Oct;27(10):645-653.e2. doi: 10.1016/j.annepidem.2017.09.003. Epub 2017 Sep 20.
PubMed 28993061Gottlieb M, Bernard K. Epidemiology of back pain visits and medication usage among United States emergency departments from 2016 to 2023. Am J Emerg Med. 2024 Aug;82:125-129. doi: 10.1016/j.ajem.2024.06.020. Epub 2024 Jun 15.
PubMed 38905718Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
PubMed 15790675Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
PubMed 22524979van Bree JB, de Boer AG, Danhof M, Ginsel LA, Breimer DD. Characterization of an "in vitro" blood-brain barrier: effects of molecular size and lipophilicity on cerebrovascular endothelial transport rates of drugs. J Pharmacol Exp Ther. 1988 Dec;247(3):1233-9.
PubMed 3204515Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol. 2013 Oct;122(4):838-844. doi: 10.1097/AOG.0b013e3182a6643c.
PubMed 24084542Shah S, Banh ET, Koury K, Bhatia G, Nandi R, Gulur P. Pain Management in Pregnancy: Multimodal Approaches. Pain Res Treat. 2015;2015:987483. doi: 10.1155/2015/987483. Epub 2015 Sep 13.
PubMed 26448875Li DK, Liu L, Odouli R. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. BMJ. 2003 Aug 16;327(7411):368. doi: 10.1136/bmj.327.7411.368.
PubMed 12919986Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.
PubMed 16824213Juganavar A, Joshi KS. Chronic Pelvic Pain: A Comprehensive Review. Cureus. 2022 Oct 26;14(10):e30691. doi: 10.7759/cureus.30691. eCollection 2022 Oct.
PubMed 36465795Hansen RN, Pham AT, Boing EA, Lovelace B, Wan GJ, Miller TE. Comparative analysis of length of stay, hospitalization costs, opioid use, and discharge status among spine surgery patients with postoperative pain management including intravenous versus oral acetaminophen. Curr Med Res Opin. 2017 May;33(5):943-948. doi: 10.1080/03007995.2017.1297702. Epub 2017 Mar 9.
PubMed 28276273Cordell WH, Keene KK, Giles BK, Jones JB, Jones JH, Brizendine EJ. The high prevalence of pain in emergency medical care. Am J Emerg Med. 2002 May;20(3):165-9. doi: 10.1053/ajem.2002.32643.
PubMed 11992334Boubred F, Vendemmia M, Garcia-Meric P, Buffat C, Millet V, Simeoni U. Effects of maternally administered drugs on the fetal and neonatal kidney. Drug Saf. 2006;29(5):397-419. doi: 10.2165/00002018-200629050-00004.
PubMed 16689556Antonucci R, Zaffanello M, Puxeddu E, Porcella A, Cuzzolin L, Pilloni MD, Fanos V. Use of non-steroidal anti-inflammatory drugs in pregnancy: impact on the fetus and newborn. Curr Drug Metab. 2012 May 1;13(4):474-90. doi: 10.2174/138920012800166607.
PubMed 22299823
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)
- ClinicalTrials.gov ID
- NCT07595302
- Acronym / sponsor ID
- PIVOTAL / 2025-17368
- Conditions
- Pelvic Pain
- Keywords
- pregnancy, acetaminophen, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio. Randomization will be performed using a computer-generated block randomization scheme, stratified by study site.
| Arm | Type | Receives |
|---|---|---|
| Oral Drug + IV Placebo | Active comparator | Drug: Acetaminophen 1000mg PO, Other: IV PlaceboOral 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. |
| Intravenous Drug + Oral Placebo | Active comparator | Drug: IV Acetaminophen 1000mg, Other: PO PlaceboIntravenous 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours
- Known allergy or intolerance to acetaminophen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen 1000mg POOral Acetaminophen 1000mg | Drug | Oral Drug + IV Placebo |
| IV Acetaminophen 1000mgIntravenous Acetaminophen 1000mg | Drug | Intravenous Drug + Oral Placebo |
| IV PlaceboIV placebo administration | Other | Oral Drug + IV Placebo |
| PO PlaceboOral placebo administration | Other | Intravenous Drug + Oral Placebo |
Primary outcome
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.
8 secondary outcomes
Pain Intensity
Time frame: 0-, 5-, 10-, 15-, 30-, 45-, 60- and 120-minutes following medication administration
Time to Clinically Meaningful Reduction in Pain
Time frame: Within 2 hours after medication administration
Use of Rescue Medications
Time frame: Within 2 hours following medication administration
Patient Global Impression of Change (PGI-C) Score
Time frame: 30- and 120-minutes following medication administration
Treatment-Related Adverse Events (TRAEs)
Time frame: Within 2 hours following medication administration
Emergency Department (ED) Disposition
Time frame: At 2 hours following medication administration
Length of Stay (LOS)
Time frame: Less than 24 hours following medication administration
Patient Satisfaction
Time frame: At 2 hours following medication administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 28742676Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
- Background: PubMed 28993061Interrante JD, Ailes EC, Lind JN, Anderka M, Feldkamp ML, Werler MM, Taylor LG, Trinidad J, Gilboa SM, Broussard CS; National Birth Defects Prevention Study. Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011. Ann Epidemiol. 2017 Oct;27(10):645-653.e2. doi: 10.1016/j.annepidem.2017.09.003. Epub 2017 Sep 20.
- Background: PubMed 38905718Gottlieb M, Bernard K. Epidemiology of back pain visits and medication usage among United States emergency departments from 2016 to 2023. Am J Emerg Med. 2024 Aug;82:125-129. doi: 10.1016/j.ajem.2024.06.020. Epub 2024 Jun 15.
- Background: PubMed 15790675Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
- Background: PubMed 22524979Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
- Background: PubMed 3204515van Bree JB, de Boer AG, Danhof M, Ginsel LA, Breimer DD. Characterization of an "in vitro" blood-brain barrier: effects of molecular size and lipophilicity on cerebrovascular endothelial transport rates of drugs. J Pharmacol Exp Ther. 1988 Dec;247(3):1233-9.
- Background: PubMed 24084542Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol. 2013 Oct;122(4):838-844. doi: 10.1097/AOG.0b013e3182a6643c.
- Background: PubMed 26448875Shah S, Banh ET, Koury K, Bhatia G, Nandi R, Gulur P. Pain Management in Pregnancy: Multimodal Approaches. Pain Res Treat. 2015;2015:987483. doi: 10.1155/2015/987483. Epub 2015 Sep 13.
- Background: PubMed 12919986Li DK, Liu L, Odouli R. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. BMJ. 2003 Aug 16;327(7411):368. doi: 10.1136/bmj.327.7411.368.
- Background: PubMed 16824213Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.
- Background: PubMed 36465795Juganavar A, Joshi KS. Chronic Pelvic Pain: A Comprehensive Review. Cureus. 2022 Oct 26;14(10):e30691. doi: 10.7759/cureus.30691. eCollection 2022 Oct.
- Background: PubMed 28276273Hansen RN, Pham AT, Boing EA, Lovelace B, Wan GJ, Miller TE. Comparative analysis of length of stay, hospitalization costs, opioid use, and discharge status among spine surgery patients with postoperative pain management including intravenous versus oral acetaminophen. Curr Med Res Opin. 2017 May;33(5):943-948. doi: 10.1080/03007995.2017.1297702. Epub 2017 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eddie M Irizarry, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen 1000mg PO and IV Acetaminophen 1000mg in people with Pelvic Pain, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustfa Manzur, MD MPH MS (718-920-6674, mmanzur@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Numeric Rating Scale (NRS) score (time frame: From baseline to 30 minutes following medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07595302, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.