Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

NCT03457116 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-01839
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.

Conditions

Rhinoplasty; Non-steroidal Ant Inflammatory Drugs; Opioid Use

Outcome Measures

Primary Outcomes (4)

• Average Pain Score

  Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

  Day 0

• Average Pain Score

  Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

  Day 1

• Average Pain Score

  Pain scores are reported via Post-Operative Pain Management Survey. On a scale of 1-10, participants indicate how much pain they were in on their pain regiment. The higher the score, the worse the pain (1 = no pain, 10 = worst pain possible)

  Day 7

• Average Post-Operative Day (POD) of Medication Cessation

  Self-reported via Post-Operative Pain Management Survey

  Day 7

Secondary Outcomes (1)

• Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain

  Day 7

Study Arms (2)

NSAIDS

ACTIVE COMPARATOR

400mg of Ibuprofen

Drug: NSAID

Opiates

ACTIVE COMPARATOR

Norco (hydrocodone 5mg- acetaminophen 325mg)

Drug: Norco

Interventions

Norco DRUG

20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)

Opiates

NSAID DRUG

Ibuprofen 400mg for post-operative pain

NSAIDS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

You may not qualify if:

• Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
• Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
• Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
• Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

oxycodone-acetaminophen; Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: Judy Lee, MD
• Organization: NYU Langone Health

Judy.Lee@nyulangone.org

(646) 501-7906

Study Officials

• Judy Lee, MD

  NYU Langone

  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: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: January 30, 2018
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data are available indefinitely at (Link to be included).
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)