Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03457116
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : May 31, 2018
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Rhinoplasty Non-steroidal Ant Inflammatory Drugs Opioid Use Drug: Norco Drug: NSAID Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Test Arm
400mg of Ibuprofen or
Ibuprofen 400mg for post-operative pain

Active Comparator: Control Arm
Norco( hydrocodone 5mg- acetaminophen 325mg)
Drug: Norco
20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)

Primary Outcome Measures :
  1. Change in overall pain control based on the Pain Management Survey [ Time Frame: Day 0, Day 1, 1 Week Post Surgery ]
    6 Question survey assessing the frequency of usage, the dose, timin and the amount of the specific analgesic consumed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: New York University School of Medicine Identifier: NCT03457116     History of Changes
Other Study ID Numbers: 17-01839
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents