Time of Intravenous Acetaminophen Administration (TIAA)
|ClinicalTrials.gov Identifier: NCT01699815|
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : August 22, 2014
Last Update Posted : September 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Time of Intravenous Acetaminophen Administration for Total Hip Arthroplasty|
|Study Start Date :||October 2012|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
Active Comparator: Preemptive group
The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.
Active Comparator: Closure group
The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.
- Changes in Postoperative Pain Scores [ Time Frame: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug ]To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain
- Pain Medication Consumption Rates [ Time Frame: Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug ]Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.
- Average Length of Stay (LOS) [ Time Frame: Baseline to discharge (1-4 days) ]To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699815
|United States, North Carolina|
|Durham Regional Hospital|
|Durham, North Carolina, United States, 27704|
|Principal Investigator:||Virginia C Muckler, DNP||Duke University Health System|