Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Phase 4

Completed

• Conditions: Tonsillectomy; Adenoidectomy
• Interventions: Drug: Acetaminophen

• Registration Number: NCT02994940
• Lead Sponsor: University of California, Davis

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-16
• Study Start: 2017-08-28
• Primary Completion: 2019-07-03
• Study Completion: 2019-07-03
• Results First Submitted: 2020-11-03
• Results First Submitted QC: 2020-12-08
• Results First Posted: 2020-12-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Acetaminophen	Acetaminophen	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.
Intravenous Acetaminophen	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
Total Dose of Opioid	Within 24hrs	Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With Severe Pain Score of 7 or Higher	24 hrs period following surgery	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.
Plasma Acetaminophen Level 1 - End of Surgery	at the end of surgery, about 1 hour after IV Dose	mg/L acetaminophen in the plasma at the end of surgery
Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration	Outcome will be measured 3hrs post first IV Dose	mg/L acetaminophen in the plasma 3 hours after IV study drug administration

Trial Locations

Locations (1)

University of California Davis Children's Hospital; 🇺🇸 Sacramento, California, United States