Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Conditions
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Tonsillectomy, Adenoidectomy

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Acetaminophen<br>Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. | Drug: Acetaminophen<br>* already included in arm/group descriptions<br>* Other names: OFIRMEV;|
| Experimental: Intravenous Acetaminophen<br>Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. | Drug: Acetaminophen<br>* already included in arm/group descriptions<br>* Other names: OFIRMEV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dose of Opioid | Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery. | Within 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Severe Pain Score of 7 or Higher | A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe. | 24 hrs period following surgery | 
| Plasma Acetaminophen Level 1 - End of Surgery | mg/L acetaminophen in the plasma at the end of surgery | at the end of surgery, about 1 hour after IV Dose | 
| Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration | mg/L acetaminophen in the plasma 3 hours after IV study drug administration | Outcome will be measured 3hrs post first IV Dose |