Time of Intravenous Acetaminophen Administration (TIAA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
| Condition | Intervention |
|---|---|
|
Osteoarthritis |
Other: No intervention for this observational study |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Time of Intravenous Acetaminophen Administration for Total Hip Arthroplasty |
- The primary aim of the study is 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. [ Time Frame: Outcome measures will be assessed preoperatively, at 6,12, 18, and 24 hours following the initial administration of the study drug, and at the time of discharge. ] [ Designated as safety issue: No ]
- A secondary aim is to compare changes in postoperative pain medication consumption rates 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. [ Time Frame: Outcome measures will be assessed preoperatively, at 6,12, 18, and 24 hours following the initial administration of the study drug, and at the time of discharge. ] [ Designated as safety issue: No ]
- A final outcome measure is to compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission. [ Time Frame: Outcome measures will be assessed preoperatively, at 6,12, 18, and 24 hours following the initial administration of the study drug, and at the time of discharge. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 138 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 for OfirmevTM administration.
|
Other: No intervention for this observational study |
|
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.
|
Other: No intervention for this observational study |
Detailed Description:
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the closure group will receive the first dose of one gram of intravenous acetaminophen administered upon onset of skin closure, 2) the preemptive group will receive the first dose of one gram of intravenous acetaminophen administered within 60 minutes prior to incision. Both groups will receive subsequent doses of one gram of intravenous acetaminophen every 6 hours x 24 hours. The maximum dose in a 24 hour period will not exceed 4 grams according to FDA recommendations.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients who are scheduled for a total hip replacement under general anesthesia.
Inclusion Criteria:
- Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.
Exclusion Criteria:
- Exclusion criteria include known allergy, hypersensitivity, or contraindication to acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients with chronic malnutrition or a body mass index (BMI) < 18 kg/m2 and non-English speaking patients. Additional exclusion criteria include impaired liver function defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine >2.0 mg/dl).
Contacts and Locations| Contact: Virginia C Muckler, DNP | 919-684-9307 | chris.muckler@duke.edu |
| United States, North Carolina | |
| Durham Regional Hospital | Recruiting |
| Durham, North Carolina, United States, 27704 | |
| Contact: Virginia C Muckler, DNP 919-684-9307 chris.muckler@duke.edu | |
| Principal Investigator: Virginia C. Muckler, DNP | |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01699815 History of Changes |
| Other Study ID Numbers: | Pro00036568 |
| Study First Received: | September 28, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
acetaminophen timing arthroplasty |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Antipyretics Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013