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Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen (MODIV-APAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02994940
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Adenoidectomy Drug: Acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
Actual Study Start Date : November 11, 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: Acetaminophen
Experimental: 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.
Drug: Acetaminophen

Primary Outcome Measures :
  1. Total Dose of Opioid [ Time Frame: After 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 :
  1. Pain Score Proportions [ Time Frame: 24hrs period following surgery ]
    A secondary endpoint is the proportion of pain scores in the mild, moderate or severe pain ranges.

  2. Plasma Acetaminophen level 1 [ Time Frame: 1 hour after IV Dose ]
    mg/L acetaminophen in the plasma

  3. Plasma Acetaminophen level 2 [ Time Frame: Outcome will be measured 3hrs post first IV Dose ]
    mg/L acetaminophen in the plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 UCDCH criteria for 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02994940

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United States, California
University of California Davis Children's Hospital
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Cathy Lammers, MD UC Davis Children's Hospital

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Responsible Party: University of California, Davis Identifier: NCT02994940     History of Changes
Other Study ID Numbers: 948256
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs