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Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty

NYU Langone Health logo

NYU Langone Health

Status and phase

Completed
Phase 4

Conditions

Opioid Use
Rhinoplasty
Non-steroidal Ant Inflammatory Drugs

Treatments

Drug: Norco
Drug: NSAID

Study type

Interventional

Funder types

Other

Identifiers

NCT03457116
17-01839

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

NSAIDS
Active Comparator group
Description:
400mg of Ibuprofen
Treatment:
Drug: NSAID
Opiates
Active Comparator group
Description:
Norco (hydrocodone 5mg- acetaminophen 325mg)
Treatment:
Drug: Norco

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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