Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

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Age: 3 to 17 years old
Gender:
Any
Healthy Volunteers: No
Type: Drug study, Phase 4
Investigator:
Description
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.
This study requires

Acetaminophen study dose administration Two blood draws through IV (one while under anesthesia)

Who can participate

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
Resources
Schedule
Study duration and period
1 hour before surgery and continuing for approximately 24 hours after surgery
Location
UC Davis Children's Hospital
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Tonsillectomy
  • Adenoidectomy

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