Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain (PIVOTAL)
Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究連絡先
研究連絡先
- 名前：Mustfa Manzur, MD MPH MS
- 電話番号：718-920-6674
- メール：mmanzur@montefiore.org
研究場所
-
-
New York
-
The Bronx、New York、アメリカ、10467
- Montefiore Medical Center
-
コンタクト：
- Mustfa Manzur, MD MPH MS
- 電話番号：718-920-6626
- メール：mmanzur@montefiore.org
-
主任研究者：
- Eddie M Irizarry, MD
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
Oral Acetaminophen 1000mg
IV placebo administration
|
|
アクティブコンパレータ：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. |
Intravenous Acetaminophen 1000mg
Oral placebo administration
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change in Numeric Rating Scale (NRS) score
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain Intensity
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Eddie M Irizarry, MD、Montefiore Medical Center
出版物と役立つリンク
一般刊行物
- Latthe 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.
- Cordell 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.
- Li 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.
- Moller 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.
- Antonucci 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.
- 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.
- Interrante 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.
- Gottlieb 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.
- Singla 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.
- van 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.
- Yazdy 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.
- Shah 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.
- Juganavar A, Joshi KS. Chronic Pelvic Pain: A Comprehensive Review. Cureus. 2022 Oct 26;14(10):e30691. doi: 10.7759/cureus.30691. eCollection 2022 Oct.
- Hansen 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.
- Boubred 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.
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- 2025-17368
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