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| ID | Type | Description | Link |
|---|---|---|---|
| IF#16-1763 | Other Identifier | Icahn School of Medicine at Mount Sinai | |
| IF#2175834 | Other Identifier | Icahn School of Medicine at Mount Sinai |
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There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.
In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Acetaminophen | Active Comparator | Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively. |
|
| Acetaminophen IV Soln | Active Comparator | Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen IV Soln | Drug | 1000mg of IV acetaminophen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PACU Visual Analogue Pain Scores | Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain. | baseline, 1 hour, and Day 1 discharge |
| Total MME Intraoperatively | Total Morphine Milligram Equivalent (MME) use intraoperatively | Day 1 |
| Total Narcotic Use in PACU. | Total narcotic use in PACU expressed in total morphine milligram equivalents (MME) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| PACU Length of Stay | Time in PACU | up to 24 hours after PACU arrival |
| Patient Reported Total Narcotic Use Post-discharge | home opiod use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Lai, MD, MPH | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West Hospital | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28742427 | Background | Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25. | |
| 15790675 | Background |
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Participants presenting for laparoscopic hernia repair under general anesthesia in an ambulatory setting were recruited from July 2017 to December 2018. First enrollment in Dec 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Acetaminophen | Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively. |
| FG001 | Acetaminophen IV Soln | Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Acetaminophen | Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively. |
| BG001 | Acetaminophen IV Soln | Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PACU Visual Analogue Pain Scores | Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain. | Posted | Mean | Standard Deviation | score on a scale | baseline, 1 hour, and Day 1 discharge |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Acetaminophen | Oral acetaminophen 975mg preoperatively and receive intravenous saline intraoperatively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alopi Patel | Icahn School of Medicine at Mount Sinai | (212) 523-6357 | Alopi.patel@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2019 | Jan 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
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| Oral Acetaminophen |
| Drug |
oral acetaminophen 975mg pills |
|
| Placebo Pills | Drug | placebo match to acetaminophen |
|
| Saline | Drug | Intravenous saline |
|
| average 7 days |
| Patient Satisfaction. | Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction | 7 days post surgery |
| 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. |
| 29200016 | Background | Olbrecht VA, Ding L, Spruance K, Hossain M, Sadhasivam S, Chidambaran V. Intravenous Acetaminophen Reduces Length of Stay Via Mediation of Postoperative Opioid Consumption After Posterior Spinal Fusion in a Pediatric Cohort. Clin J Pain. 2018 Jul;34(7):593-599. doi: 10.1097/AJP.0000000000000576. |
| 31669049 | Result | Patel A, Pai B H P, Diskina D, Reardon B, Lai YH. Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial. J Clin Anesth. 2020 May;61:109628. doi: 10.1016/j.jclinane.2019.109628. Epub 2019 Oct 25. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Total MME Intraoperatively | Total Morphine Milligram Equivalent (MME) use intraoperatively | Posted | Mean | Standard Deviation | MME | Day 1 |
|
|
|
| Primary | Total Narcotic Use in PACU. | Total narcotic use in PACU expressed in total morphine milligram equivalents (MME) | Posted | Mean | Standard Deviation | MME | Day 1 |
|
|
|
| Secondary | PACU Length of Stay | Time in PACU | Posted | Mean | Standard Deviation | minutes | up to 24 hours after PACU arrival |
|
|
|
| Secondary | Patient Reported Total Narcotic Use Post-discharge | home opiod use | Posted | Mean | Standard Deviation | MME | average 7 days |
|
|
|
| Secondary | Patient Satisfaction. | Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction | one missing survey | Posted | Mean | Standard Deviation | score on a scale | 7 days post surgery |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Acetaminophen IV Soln | Acetaminophen 1000mg IV Soln after induction of general anesthesia and placebo pills preoperatively | 0 | 44 | 0 | 44 | 0 | 44 |
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| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |