NCT02994940

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tonsillectomy
• Adenoidectomy

Interventions

Type	Name	Description
DRUG	Acetaminophen	already included in arm/group descriptions

Timeline

• Start date: 2017-08-28
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2016-12-16
• Last updated: 2021-02-18
• Results posted: 2020-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study