Efficacy of Oral vs. Intravenous Acetaminophen
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|ClinicalTrials.gov Identifier: NCT02643394|
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : May 7, 2018
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Oral Acetaminophen Drug: Intravenous acetaminophen||Phase 4|
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen is understudied and largely unknown. Intravenous acetaminophen has been available since 2010 (http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf) and has proven superiority over placebo in human clinical trials. It is clearly advantageous in patients who cannot take oral medications. Similarly, oral acetaminophen has proven efficacy in the management of postoperative pain.
However, in patients who can receive either formulation the incremental cost of the IV formulation, both to the Health System and patient, is substantial. This incremental cost would be justifiable if there were clear efficacy or safety data to support the preferential use of IV over PO acetaminophen.
However, there is no evidence of superior safety and there are only two studies to our knowledge investigating the question of comparative efficacy. Fenlon et al. randomized 130 patients undergoing 3rd molar (i.e., wisdom tooth) removal to IV vs. PO acetaminophen and found that PO acetaminophen was non-inferior to IV acetaminophen. The primary endpoint was postoperative pain score 1h after surgery. No safety concerns were identified in either group. Pettersson et al. randomized cardiac surgery patients to IV or PO acetaminophen, starting immediately postoperatively through the following morning, and found a significant opioid sparing effect of IV acetaminophen but no difference in pain scores or nausea.
IV acetaminophen avoids first-pass hepatic metabolism and therefore generates higher serum and cerebrospinal fluid (CSF)/brain levels than does PO acetaminophen (http://ofirmev.com/Pharmacokinetics/). Based on the pharmacokinetic data, one can hypothesize that IV acetaminophen would be superior to PO acetaminophen at time points where serum and/or cerebrospinal fluid drug levels are higher.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Comparative Efficacy of Oral vs. Intravenous Acetaminophen in Sinus Surgery Patients|
|Actual Study Start Date :||August 17, 2015|
|Actual Primary Completion Date :||September 2, 2016|
|Actual Study Completion Date :||January 15, 2018|
Active Comparator: Oral Acetaminophen
Oral Acetaminophen 1-hour before surgery
Drug: Oral Acetaminophen
1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision
Other Name: Tylenol
Active Comparator: Intravenous Acetaminophen
Intravenous Acetaminophen within 1-hour prior to anesthetic emergence
Drug: Intravenous acetaminophen
400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Other Name: Tylenol
- Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain) [ Time Frame: 1-h postoperatively ]Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)
- Morphine Equivalents of Postoperative Opioid Usage [ Time Frame: an expected average of 6 hours ]Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 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): NCT02643394
|United States, Texas|
|Zale Lipshy University Hospital|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||David McDonagh, MD||UT Southwestern Medical Center|