Postoperative Pain Control in Septum and Sinus Surgery

NCT04149964 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2019-259
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Post-operative pain; Sinus pain; Sinus surgery; Septum Pain; deviated septum

Outcome Measures

Primary Outcomes (1)

• Number of Doses of Opiate (Narcotic) Pain Medication

  Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week.

  7 days

Secondary Outcomes (8)

• Highest Subjective Pain Score

  7 days

• Lowest Subjective Pain Score

  7 days

• Percentage of Time Participant Experienced Severe Pain

  7 days

• Participant Use of Acetaminophen as Needed

  7 days

• Participant Use of Scheduled Acetaminophen Around the Clock

  7 days

Study Arms (2)

Standard of Care arm

ACTIVE COMPARATOR

Standard of Care Post-operative pain medication, Acetaminophen 325 mg every 6 hours as needed for pain plus acetaminophen/hydrocodone 7.5 mg/325 mg 1 tab every 4 hours as needed for pain.

Drug: Acetaminophen 325 mg Oral Tablet; Drug: Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet

Study Arm

EXPERIMENTAL

Acetaminophen 650 mg 1 tab every 6 hours round the clock plus Oxycodone 5 mg 1 tab every 6 hours as needed for breakthrough pain,.

Drug: Acetaminophen 650 mg Oral Tablet; Drug: OxyCODONE 5 mg Oral Tablet

Interventions

Acetaminophen 325 mg Oral Tablet DRUG

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

Also known as: Tylenol Standard Strength

Standard of Care arm

Acetaminophen 650 mg Oral Tablet DRUG

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

Also known as: Tylenol Extra Strength

Study Arm

OxyCODONE 5 mg Oral Tablet DRUG

Oxycodone 5 mg every 4 hours as needed for breakthrough pain

Also known as: Percodan, Percocet

Study Arm

Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet DRUG

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

Also known as: Norco

Standard of Care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing primary sinus surgery, primary septum surgery, or primary sinus/septum surgery
• years of age or older
• Male or female
• No known allergies to or contraindications to the use of acetaminophen, hydrocodone, or oxycodone
• Patients discharged to home after surgery

You may not qualify if:

• Undergoing revision sinus, septum, or sinus/septum surgery
• Younger than 18 years old
• Allergy or contraindication to acetaminophen, hydrocodone, or oxycodone
• Patients admitted to the hospital postoperatively for airway monitoring

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital

Farmington Hills, Michigan, 48336, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Tablets; Oxycodone; Aspirin-oxycodone hydrochloride-oxycodone terephthalate combination; oxycodone-acetaminophen; Hydrocodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Mitchell Shecter, DO
• Organization: William Beaumont Hospitals

mitchell.shecter@corewellhealth.org

2487629363

Study Officials

• David Seel, DO.

  William Beaumont Hospital - Farmington Hills

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open, randomized into one of two arms study. Study arm 1: Standard of care arm of Acetaminophen (Tylenol) 325 mg every 6 hours as needed plus acetaminophen/hydrocodone 7.5 mg/325mg every 4 hours for breakthrough pain. Study arm 2: Acetaminophen 650 mg. every 6 hours round the clock plus 5 mg oxycodone every 4 hours as needed for breakthrough pain.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: November 27, 2019
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: August 31, 2023
• Results First Posted: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)