Skip to main content
OpenTrials
Completed

NCT Number: NCT03457116

Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rhinoplasty Non-steroidal Ant Inflammatory Drugs Opioid Use

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Norco

Drug

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

NSAID

Drug

Ibuprofen 400mg for post-operative pain

Primary outcomes

  1. Average Pain Score

    Time frame: Day 0

    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)

  2. Average Pain Score

    Time frame: Day 1

    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)

  3. Average Pain Score

    Time frame: 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)

  4. Average Post-Operative Day (POD) of Medication Cessation

    Time frame: Day 7

    Self-reported via Post-Operative Pain Management Survey

Secondary outcomes

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

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2018
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.