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The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen First | Experimental | Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive acetaminophen first. |
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| Placebo First | Experimental | Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive placebo first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen 1 g intravenous given at the beginning and end of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Opioid Consumption | From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl. | Up to 24 hours post-operative |
| Post-operative Pain | Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group. | Up to 24 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Requiring Anti-emetic Administration | Up to 24 hours post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen First, Then Placebo | Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first. |
| FG001 | Placebo First, Then Acetaminophen | Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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Participants who completed both interventions were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Post-operative Opioid Consumption | From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl. | Participants who completed both interventions were included in the analysis. | Posted | Mean | Standard Deviation | ug | Up to 24 hours post-operative |
|
Up to 2 weeks
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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 | Acetaminophen | Patients were administered intravenous acetaminophen (1 g IV) twice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Burbridge | Stanford University | (650) 353-8484 | markburb@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2013 | Sep 19, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients selected for this study were being treated for Moyamoya disease and required two operations, scheduled 1-2 weeks apart. With random assignment, patients were administered 1 gram of intravenous acetaminophen at the beginning and end of surgery, and placebo during the other operation.
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| Placebo | Drug | Placebo to match acetaminophen given at the beginning and end of surgery. |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Post-operative Pain | Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group. | Participants who completed both interventions were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Up to 24 hours post-operative |
|
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| Secondary | Count of Participants Requiring Anti-emetic Administration | Participants who completed both interventions were included in the analysis. | Posted | Count of Participants | Participants | Up to 24 hours post-operative |
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|
|
| 2 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | Patients were administered placebo to match acetaminophen. | 2 | 25 | 0 | 25 | 0 | 25 |
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| Aniline Compounds |
| D000588 | Amines |
| Post-operative hour 0 to 24 |
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