CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
Acetaminophen 325 mg Oral Tablet +3 moredrug
Likely dose
Acetaminophen 325 mg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04149964
NCT04149964Phase 4Completed

Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach.

Corewell Health East·interventional·Posted Nov 4, 2019·Updated Aug 31, 2023

In Brief

A Phase 4 clinical trial evaluating Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet, and 2 other interventions for Post-operative Pain and Sinus Surgery. Completed, enrolled 65 participants across 1 site.

Detailed Summary

This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients. Participants will be randomized like a flip of a coin to either the standard of care pain treatment of acetaminophen 325 mg as needed for pain plus opiates (acetaminophen/hydrocodone) as needed for breakthrough pain; OR to the study arm of acetaminophen 650 mg every 6 hours plus opiates (Oxycodone)as needed for breakthrough pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 4, 2019
Enrollment StartNov 27, 2019
Primary CompletionSep 21, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.7 years ago

Interventions

Acetaminophen 325 mg Oral Tabletdrug

Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain

Acetaminophen 650 mg Oral Tabletdrug

Acetaminophen 650 mg scheduled every 6 hours round the clock for pain

OxyCODONE 5 mg Oral Tabletdrug

Oxycodone 5 mg every 4 hours as needed for breakthrough pain

Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tabletdrug

Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain