A Phase 4 interventional study of Oral Acetaminophen and Intravenous acetaminophen in Postoperative Pain, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 110 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inability of the patient to follow directions or comprehend either English or Spanish language.
Oral Acetaminophen 1-hour before surgery
Drug: Oral Acetaminophen
Intravenous Acetaminophen within 1-hour prior to anesthetic emergence
Drug: Intravenous acetaminophen
1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision
Also known as: Tylenol
400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Also known as: Tylenol
Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)
Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)
Time frame: 1-h postoperatively
Morphine Equivalents of Postoperative Opioid Usage
Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours
Time frame: an expected average of 6 hours
| Milestone | Oral Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Started | 55 | 55 |
| Completed | 51 | 50 |
| Not completed | 4 | 5 |
| Withdrew: Protocol violation | 4 | 5 |
Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)
| units on a scale | Oral Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain) | 2 (0 to 3) | 2 (0 to 5) |
Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours
| Morphine equivalent (mg) | Oral Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Morphine Equivalents of Postoperative Opioid Usage | 5 (0 to 10) | 5 (0 to 14.8) |
Collected over Through 24h post-operatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Acetaminophen | 0/51 (0%) | 0/51 (0%) | 3/51 (5.9%) |
| Intravenous Acetaminophen | 0/50 (0%) | 0/50 (0%) | 6/50 (12%) |
| Event | Oral Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| NauseaGastrointestinal disorders | 3/51 | 6/50 |
Adult patients undergoing sinus surgery at a single major academic medical center
| Age, Categorical(Participants) | Oral Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 44 | 42 | 86 |
| >=65 years | 11 | 13 | 24 |
| Age, Continuous(years) | Oral Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Mean | 51.5 ± 16.3 | 54.0 ± 15.7 | 52.7 ± 16.0 |
| Sex: Female, Male(Participants) | Oral Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Female | 21 | 20 | 41 |
| Male | 34 | 35 | 69 |
| Region of Enrollment(participants) | Oral Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| United States | 55 | 55 | 110 |
Plan to share: No
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University of Texas Southwestern Medical Center