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Completed

NCT Number: NCT02994940

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

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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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California Davis Children's Hospital

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

already included in arm/group descriptions

Other names: OFIRMEV

Primary outcomes

  1. Total Dose of Opioid

    Time frame: Within 24hrs

    Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.

Secondary outcomes

  1. Proportion of Patients With Severe Pain Score of 7 or Higher

    Time frame: 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.

  2. Plasma Acetaminophen Level 1 - End of Surgery

    Time frame: at the end of surgery, about 1 hour after IV Dose

    mg/L acetaminophen in the plasma at the end of surgery

  3. Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration

    Time frame: Outcome will be measured 3hrs post first IV Dose

    mg/L acetaminophen in the plasma 3 hours after IV study drug administration

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Acronym: MODIV-APAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2016
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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