Intravenous Acetaminophen for Craniotomy Patients (IVAC)
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|ClinicalTrials.gov Identifier: NCT01474304|
Recruitment Status : Recruiting
First Posted : November 18, 2011
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Craniotomy||Drug: Acetaminophen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||June 2017|
Active Comparator: Acetaminophen
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.
1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
No Intervention: No acetaminophen
Patients will receive standard of care with no intraoperative doses of acetaminophen.
- Total narcotic dose administered over the first 12 hours of postoperative recovery. [ Time Frame: 12 hours ]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.
- Incidence of nausea during postoperative recovery [ Time Frame: 12 hours ]
- Incidence of vomiting during postoperative recovery [ Time Frame: 12 hours ]
- Severity of nausea during postoperative recovery [ Time Frame: 12 hours ]
- Severity of vomiting during postoperative recovery [ Time Frame: 12 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474304
|Contact: Becky Woodfirstname.lastname@example.org|
|Contact: Nathan Hansenemail@example.com|
|United States, Washington|
|Swedish Medical Center Cherry Hill Campus||Recruiting|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Arthur Lam, MD, FRCPC||Swedish Medical Center|