Summary

for people ages 3-17 (full criteria)
at Sacramento, California
study started
estimated completion
Cathy Lammers

Description

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.

Official Title

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Details

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.

Keywords

Tonsillectomy Adenoidectomy Acetaminophen Oral Acetaminophen Intravenous Acetaminophen

Eligibility

You can join if…

Open to people ages 3-17

  • 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).

You CAN'T join if...

  • 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

Location

  • University of California Davis Children's Hospital accepting new patients
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT02994940
Phase
Phase 4
Study Type
Interventional
Last Updated