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| ID | Type | Description | Link |
|---|---|---|---|
| 20111619 | Other Identifier | Western Institutional Review Board (WIRB) |
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | Craniotomy patients will receive a 1000 mg dose of intravenous (IV) acetaminophen before incision and a second 1000 mg dose of IV acetaminophen 6 hours later. |
|
| No acetaminophen | No Intervention | Patients will receive standard of care with no intraoperative doses of acetaminophen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | 1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Total narcotic dose administered over the first 12 hours of postoperative recovery. | Intensive care nurses will ask subject about pain and nausea every 15 minutes for the first two hours immediately after surgery and then every hour afterward for up to 12 hours. Nurses will record subject response and opioid doses given. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nausea during postoperative recovery | 12 hours | |
| Incidence of vomiting during postoperative recovery | 12 hours | |
| Severity of nausea during postoperative recovery |
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Inclusion Criteria:
At least 18 years of age
Weigh at least 50 kg (110.23 lbs)
Undergoing open, elective intracranial procedure for
Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
Able to provide written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Becky Wood | Contact | 206-320-7115 | becky.wood@swedish.org | |
| Nathan Hansen | Contact | 206-320-3542 | nathan.hansen@swedish.org |
| Name | Affiliation | Role |
|---|---|---|
| Arthur Lam, MD, FRCPC | Swedish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center Cherry Hill Campus | Recruiting | Seattle | Washington | 98122 | United States |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | 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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| 12 hours |
| Severity of vomiting during postoperative recovery | 12 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |