Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2019-07-03

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.

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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.

Conditions

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Tonsillectomy Adenoidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oral 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.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

already included in arm/group descriptions

Intravenous 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.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

already included in arm/group descriptions

Interventions

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Acetaminophen

already included in arm/group descriptions

Intervention Type DRUG

Other Intervention Names

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OFIRMEV

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No