Clinical trial NCT02994940: Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
Official title: Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillectomy
Adenoidectomy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 74
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Total Dose of Opioid
timeFrame: Within 24hrs
Secondary outcomes:
measure: Proportion of Patients With Severe Pain Score of 7 or Higher
timeFrame: 24 hrs period following surgery
measure: Plasma Acetaminophen Level 1 - End of Surgery
timeFrame: at the end of surgery, about 1 hour after IV Dose
measure: Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration
timeFrame: Outcome will be measured 3hrs post first IV Dose
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Children's Hospital
state: California
Study officials:
affiliation: UC Davis Children's Hospital
name: Cathy Lammers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lammers CR, Schwinghammer AJ, Hall B, Kriss RS, Aizenberg DA, Funamura JL, Senders CW, Nittur V, Applegate RL 2nd. Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1568-1576. doi: 10.1213/ANE.0000000000005678.