Efficacy of Oral vs. Intravenous Acetaminophen
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 7/5/2018 |
| Start Date: | August 17, 2015 |
| End Date: | January 15, 2018 |
The Comparative Efficacy of Oral vs. Intravenous Acetaminophen in Sinus Surgery Patients
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.
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.
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.
Inclusion Criteria:
- Adult patients aged 18 years or older
- Undergoing elective sinus surgery at Zale Lipshy Hospital
Exclusion Criteria:
- Inability of the patient to follow directions or comprehend either English or Spanish
language.
- Disorders of the liver which would make acetaminophen contraindicated (such as
hepatitis, liver failure, prior liver transplant, etc).
- Patients with chronic pain manifest by a baseline pain score > 4/10
- Chronic opioid use (>2 weeks continuously), or illicit drug abuse
- Body weight < 50 kg.
- Patients with contraindications to any of the study drugs (such as Malignant
Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
- Patients who have taken analgesic medications on the morning of surgery (prior to
arrival).
- Allergy to acetaminophen
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