Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

Opioid Use Clinical Trial

Official title:

Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457116
• Other study ID #: 17-01839
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2018
• Est. completion date: November 2, 2020

Study information

• Verified date: October 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-steroidal Ant Inflammatory Drugs
• Opioid Use
• Rhinoplasty

Intervention

Drug:
• Norco
20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
• NSAID
Ibuprofen 400mg for post-operative pain

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Average Post-Operative Day (POD) of Medication Cessation	Self-reported via Post-Operative Pain Management Survey	Day 7
Secondary	Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain		Day 7