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The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.
This study will use a randomized, double-blind, controlled design with two arms:
Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively
120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: IV Acetaminophen group | Experimental | Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively |
|
| Arm 2: PO Acetaminophen group | Active Comparator | Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Pain | Pain measured from 0 (no pain) to 10 (worst pain) | through study visit, less than 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Opioid Administration in PACU | Number of Participants who Received Opioid Administration in PACU | through study visit, less than 24 hours |
| Number of Participants Who Experienced Postoperative Nausea and Vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth, Bethesda Butler Hospital | Cincinnati | Ohio | 45011 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: IV Acetaminophen Group | Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule |
| FG001 | Arm 2: PO Acetaminophen Group | Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: IV Acetaminophen Group | Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule |
| BG001 |
| 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 | Patient Reported Pain | Pain measured from 0 (no pain) to 10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale | through study visit, less than 24 hours |
|
10 months
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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 | Arm 1: IV Acetaminophen Group | Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurse Researcher | TriHealth | 513-569-6191 | Rachel_Baker2@trihealth.com |
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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 | Mar 1, 2018 | Apr 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This study will use a randomized, double-blind, placebo controlled design with two arms.
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Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
| PO Acetaminophen | Drug | Acetaminophen PO 1000mg once pre-operatively |
|
|
| PO Placebo | Drug | PO placebo capsule compounded to match PO Acetaminophen capsule |
|
| IV Solution Placebo | Drug | This will serve as the placebo for the IV Acetaminophen intervention |
|
|
Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
| through study visit, less than 24 hours |
| Length of Stay | Minutes from entering PACU to end of Phase II | through study visit, less than 24 hours |
| Patient Satisfaction | Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied) | up to 2 days after surgery |
| Arm 2: PO Acetaminophen Group |
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention |
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants Who Received Opioid Administration in PACU | Number of Participants who Received Opioid Administration in PACU | Posted | Count of Participants | Participants | through study visit, less than 24 hours |
|
|
|
| Secondary | Number of Participants Who Experienced Postoperative Nausea and Vomiting | Did patient experience negative effects of pain medication (postoperative nausea and vomiting) | Posted | Count of Participants | Participants | through study visit, less than 24 hours |
|
|
|
| Secondary | Length of Stay | Minutes from entering PACU to end of Phase II | Posted | Mean | Standard Deviation | minutes | through study visit, less than 24 hours |
|
|
|
| Secondary | Patient Satisfaction | Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied) | Posted | Mean | Standard Deviation | score on a scale | up to 2 days after surgery |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Arm 2: PO Acetaminophen Group | Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention | 0 | 60 | 0 | 60 | 0 | 60 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |