Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.
The primary purpose of this study is to compare opioid utilization in post-operative patients undergoing tonsillectomy and adenoidectomy, between IV and PO acetaminophen. Secondarily, it will provide information regarding possible cost savings, pharmacokinetics and safety between these two regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
already included in arm/group descriptions
University of California Davis Children's Hospital
Sacramento, California, United States
Total Dose of Opioid
Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.
Time frame: Within 24hrs
Proportion of Patients With Severe Pain Score of 7 or Higher
A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe.
Time frame: 24 hrs period following surgery
Plasma Acetaminophen Level 1 - End of Surgery
mg/L acetaminophen in the plasma at the end of surgery
Time frame: at the end of surgery, about 1 hour after IV Dose
Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration
mg/L acetaminophen in the plasma 3 hours after IV study drug administration
Time frame: Outcome will be measured 3hrs post first IV Dose
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