Phase 4
N=70
Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty
Rhinoplasty · Non-steroidal Ant Inflammatory Drugs · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT03457116 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Average Pain Score — 2.54; 3.14 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Norco (Drug); NSAID (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Score |
3.29; 3.14 | — |
| PRIMARY Average Pain Score |
3.29; 3.14 | — |
| PRIMARY Average Pain Score |
3.29; 3.14 | — |
| PRIMARY Average Post-Operative Day (POD) of Medication Cessation |
4.73; 4.28 | — |
| SECONDARY Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain |
5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03457116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.