Acetaminophen's Efficacy For Post-operative Pain

Status Completed

Clinical Trial Summary

The purpose of this study is to compare IV acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01721486
Study type	Interventional
Source	William Beaumont Hospitals
Contact
Status	Completed
Phase	Phase 4
Start date	September 2012
Completion date	January 2015

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