Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Phase 4 Completed 74 enrolled University of California, Davis

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2017-08-28
Primary completion: 2019-07-03
Completion: 2019-07-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Oral Acetaminophen vs Intravenous Acetaminophen; p = 0.127; NCT02994940 ↗

Publications

Lammers CR, Schwinghammer AJ, Hall B, Kriss RS, Aizenberg DA, Funamura JL, Senders CW, Nittur V, Applegate RL 2nd. Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1568-1576. doi: 10.1213/ANE.0000000000005678.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	15 mg/kg	Oral
Subject	Acetaminophen	Small molecule	30 mg/kg	Oral