A Phase 4 interventional study of Norco and NSAID in Rhinoplasty, Non-steroidal Ant Inflammatory Drugs and Opioid Use, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
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.
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
400mg of Ibuprofen
Drug: NSAID
Norco (hydrocodone 5mg- acetaminophen 325mg)
Drug: Norco
Drug pages: Hydrocodone · Acetaminophen
20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
Ibuprofen 400mg for post-operative pain
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
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
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
Average Post-Operative Day (POD) of Medication Cessation
Self-reported via Post-Operative Pain Management Survey
Time frame: Day 7
Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain
Time frame: Day 7
| Milestone | NSAIDS | Opiates |
|---|---|---|
| Started | 41 | 29 |
| Completed | 41 | 29 |
| Not completed | 0 | 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)
| score on a scale | NSAIDS | Opiates |
|---|---|---|
| Average Pain Score | 2.54 ± 1.57 | 3.14 ± 1.75 |
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)
| score on a scale | NSAIDS | Opiates |
|---|---|---|
| Average Pain Score | 1.84 ± 1.29 | 2.46 ± 1.90 |
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)
| score on a scale | NSAIDS | Opiates |
|---|---|---|
| Average Pain Score | 3.29 ± 2.14 | 3.14 ± 2.12 |
Self-reported via Post-Operative Pain Management Survey
| days | NSAIDS | Opiates |
|---|---|---|
| Average Post-Operative Day (POD) of Medication Cessation | 4.73 ± 1.57 | 4.28 ± 2.23 |
| Participants | NSAIDS |
|---|---|
| Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain | 5 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NSAIDS | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Opiates | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | NSAIDS | Opiates | Total |
|---|---|---|---|
| Mean | 32 (19 to 70) | 32 (21 to 64) | 32 (19 to 70) |
| Sex: Female, Male(Participants) | NSAIDS | Opiates | Total |
|---|---|---|---|
| Female | 19 | 12 | 31 |
| Male | 22 | 17 | 39 |
| Race (NIH/OMB)(Participants) | NSAIDS | Opiates | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 41 | 29 | 70 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data are available indefinitely at (Link to be included).
Access criteria: Anyone who wishes to access the data.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Hydrocodone · Acetaminophen · Anti-Inflammatory Agents, Non-Steroidal