Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Completed · Phase 4

Conditions studied: Tonsillectomy, Adenoidectomy

In brief

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.

Key facts

Study ID

NCT02994940

Run by

University of California, Davis

People needed

74

Starts

2017-08-28

Expected to finish

2019-07-03

Last updated by the study team

2021-02-18

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• University of California Davis Children's Hospital — Sacramento, California, United States

Full record on ClinicalTrials.gov

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