Airway Obstruction Clinical Trial
Official title:
Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy
The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.
Tonsillectomy with or without adenoidectomy is a common surgical procedure in children and
adolescents. Usually performed for recurrent tonsillitis or symptoms of airway obstruction,
the procedure can result in significant post-operative pain. Common analgesic techniques
include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), such
as ibuprofen by mouth (PO) or ketorolac intravenous (IV), and narcotics. Acetaminophen has
been shown to be effective in reducing pain and post-operative opioid requirements. Its
administration can be oral, rectal, or intravenous. NSAIDs, though effective for pain
control, have been shown to increase bleeding risk and disrupt hemostasis. Narcotics are
effective for pain control but increase the risk of nausea and vomiting. They also have the
potential to cause respiratory depression.
IV acetaminophen (OFIRMEV) is indicated for management of mild to moderate pain, and as an
adjunct to opioids for severe pain. Several studies have examined the efficacy of IV
acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (PR),
tramadol). IV acetaminophen has been shown to be superior to placebo for pain control.
Though there is data regarding peak plasma and Cerebral Spinal Fluid (CSF) concentration of
acetaminophen when given by different routes (PO vs IV vs PR), there is no data comparing
the efficacy of oral vs IV administration for pain control post-tonsillectomy in children.
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