Overview

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Status:
Completed
Trial end date:
2019-07-03
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Davis
Treatments:
Acetaminophen
Criteria
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 University of California Davis Children's Hospital (UCDCH) criteria
for Pediatric Intensive Care Unit (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 Glucose-6-phosphate dehydrogenase (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