Rhinoplasty, Non-steroidal Ant Inflammatory Drugs, Opioid Use
Conditions
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.
Interventions
DRUGNorco
20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
DRUGNSAID
Ibuprofen 400mg for post-operative pain
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Post-Operative Day (POD) of Medication Cessation | Day 7 | Self-reported via Post-Operative Pain Management Survey |
| Average Pain Score | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain | Day 7 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NSAIDS 400mg of Ibuprofen
NSAID: Ibuprofen 400mg for post-operative pain | 41 |
| Opiates Norco (hydrocodone 5mg- acetaminophen 325mg)
Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco) | 29 |
| Total | 70 |
Baseline characteristics
| Characteristic | Opiates | Total | NSAIDS |
|---|---|---|---|
| Age, Continuous | 32 years | 32 years | 32 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 70 Participants | 41 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 31 Participants | 19 Participants |
| Sex: Female, Male Male | 17 Participants | 39 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 29 |
| other Total, other adverse events | 0 / 41 | 0 / 29 |
| serious Total, serious adverse events | 0 / 41 | 0 / 29 |
Outcome results
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)
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAIDS | Average Pain Score | 3.29 score on a scale | Standard Deviation 2.14 |
| Opiates | Average Pain Score | 3.14 score on a scale | Standard Deviation 2.12 |
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)
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAIDS | Average Pain Score | 2.54 score on a scale | Standard Deviation 1.57 |
| Opiates | Average Pain Score | 3.14 score on a scale | Standard Deviation 1.75 |
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)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAIDS | Average Pain Score | 1.84 score on a scale | Standard Deviation 1.29 |
| Opiates | Average Pain Score | 2.46 score on a scale | Standard Deviation 1.9 |
Primary
Average Post-Operative Day (POD) of Medication Cessation
Self-reported via Post-Operative Pain Management Survey
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NSAIDS | Average Post-Operative Day (POD) of Medication Cessation | 4.73 days | Standard Deviation 1.57 |
| Opiates | Average Post-Operative Day (POD) of Medication Cessation | 4.28 days | Standard Deviation 2.23 |
Secondary
Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain
Time frame: Day 7
Population: This outcome measure is only applicable to NSAIDS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NSAIDS | Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain | 5 Participants |