Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen



Status:Recruiting
Healthy:No
Age Range:3 - 17
Updated:1/17/2019
Start Date:November 11, 2016
End Date:October 2019
Contact:Cathy Lammers, MD
Email:crlammers@ucdavis.edu
Phone:9167342028

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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.

Inclusion Criteria:

- Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for
obstructive sleep apnea with or without additional minor procedures such as sleep
endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or
ear exam. ( Minor additional procedures that are frequently combined with
tonsillectomy and adenoidectomy but are not commonly considered to have pain that is
significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

- Patients who meet UCDCH criteria for PICU admission: on home oxygen pre-operatively,
exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep
study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%,
cardiac disease, difficult intubation.

- Patients with a known allergy to acetaminophen

- Patients with known hepatic insufficiency or severe hepatic disease

- Patients with known G6PD deficiency

- Patients who are malnourished (ie lower levels of glutathione)

- Patients with severe renal impairment as defined by calculated creatinine clearance
<20 ml/min (per modified Schwarz equation)

- Patients who are pregnant
We found this trial at
1
site
Sacramento, California 95817
Phone: 916-734-5028
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mi
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Sacramento, CA
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