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The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen & Craniotomy | Experimental | Drug: Acetaminophen 1000mg administered intravenously during craniotomy |
|
| Placebo & Craniotomy | Placebo Comparator | Placebo administered intravenously during craniotomy. |
|
| Acetaminophen & Laminectomy | Experimental | Acetaminophen 1000mg administered intravenously during laminectomy. |
|
| Placebo & Laminectomy | Placebo Comparator | Placebo administered during laminectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen or Placebo | Drug | Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively". |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours). | 1hour -6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid administration | Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups. | 1 hour-6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitar Dentchev, MD | Contact | 210-916-2118 | dimitar.i.dentchev.civ@mail.mil |
| Name | Affiliation | Role |
|---|---|---|
| Dimitar Dentchev, MD | BAMC | Principal Investigator |
| Betsy Murray, MD | BAMC | Study Chair |
| Robert Vietor, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Recruiting | San Antonio | Texas | 78234 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| BAMC |
| Study Chair |
| Jonathan Deeth, MD | BAMC | Study Chair |
| Daniel Stypula, DO | BAMC | Study Chair |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |