Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

Phase 4

Completed

• Conditions: Non-steroidal Ant Inflammatory Drugs; Rhinoplasty; Opioid Use
• Interventions: Drug: Norco; Drug: NSAID

• Registration Number: NCT03457116
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Status Verified: 2021-10
• Results First Submitted: 2021-10-25
• Results First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Results First Posted: 2021-11-23
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opiates	Norco	Norco (hydrocodone 5mg- acetaminophen 325mg)
NSAIDS	NSAID	400mg of Ibuprofen

Primary Outcome Measures

Name	Time	Method
Average Post-Operative Day (POD) of Medication Cessation	Day 7	Self-reported via Post-Operative Pain Management Survey
Average Pain Score	Day 7	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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain	Day 7

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States