MedTrace Logo

Postoperative Pain Control in Septum and Sinus Surgery

NCT04149964 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-08-31

Study results available
· View outcomes & findings →

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.

Conditions

  • Post-operative Pain
  • Sinus Surgery

Interventions

DRUG

Acetaminophen 325 mg Oral Tablet

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

DRUG

Acetaminophen 650 mg Oral Tablet

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

DRUG

OxyCODONE 5 mg Oral Tablet

Oxycodone 5 mg every 4 hours as needed for breakthrough pain

DRUG

Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet

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

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • David Seel, DO. · William Beaumont Hospital - Farmington Hills

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-27
Primary Completion
2022-09-21
Completion
2022-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149964 on ClinicalTrials.gov