NCT02643394

Efficacy of Oral vs. Intravenous Acetaminophen

Completed Phase 4 Results posted Last updated 21 April 2020

What this trial tests

Phase 4 trial testing Oral Acetaminophen in Postoperative Pain in 110 participants. Completed in 15 January 2018.

Timeline

17 August 2015

Primary endpoint
2 September 2016

15 January 2018

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	110
Start date	17 August 2015
Primary completion	2 September 2016
Estimated completion	15 January 2018
Sites	1 location across United States

Drugs / interventions tested

• Oral Acetaminophen
• Intravenous acetaminophen — full drug profile →

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 80, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain) Primary · 1-h postoperatively

Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)

Group	Value	95% CI
Oral Acetaminophen	2	0 – 3
Intravenous Acetaminophen	2	0 – 5

Morphine Equivalents of Postoperative Opioid Usage Secondary · an expected average of 6 hours

Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours

Group	Value	95% CI
Oral Acetaminophen	5	0 – 10
Intravenous Acetaminophen	5	0 – 14.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Through 24h post-operatively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Acetaminophen

Serious: 0/51 (0%)

Deaths: 0/51

Intravenous Acetaminophen

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	Oral Acetaminophen	Intravenous Acetaminophen
Nausea	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT02643394 adverse events section.

Sponsor's own description

The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intravenous vs oral acetaminophen in sinus surgery: A randomized clinical trial.
   Bhoja R, Ryan MW, Klein K, Minhajuddin A, et al · · 2020 · cited 9× · PMID 32596476 · DOI 10.1002/lio2.375