Phase 2
N=141
Postoperative Pain Management in Rhinoplasty
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03584152 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) — 44; 41 score on a scale — p=0.156
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Norco 5Mg-325Mg Tablet (Drug); Tylenol 325Mg Caplet (Drug); Ibuprofen 200 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) |
44; 41 | 0.156 |
| SECONDARY Number of Study Drugs (Doses) Utilized |
16; 19 | 0.112 |
| SECONDARY Number of Tramadol Doses Utilized |
1; 2.0 | 0.803 |
| SECONDARY Number Patients Who Reported Adequate Pain Control |
4; 2; 61; 63 | 0.403 |
| SECONDARY Side Effects of Pain Medications |
17; 13; 14; 2; 22; 19 | 0.405 |
| SECONDARY Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire |
40.0; 41.0; -25.7; -23.4; 54.0; 54.0 | 0.7318 |
| SECONDARY Visual Analog Scale-Functional (VAS-F) |
4.0; 4.0; -1.8; -1.8 | 0.9158 |
| SECONDARY Visual Analog Scale-Aesthetic (VAS-A) |
3.0; 3.0; -1.5; -1.2 | 0.5351 |
| SECONDARY Eyelid Edema Score |
0; 0 | 0.378 |
| SECONDARY Ecchymosis Score |
0; 0 | 0.195 |
| SECONDARY Subconjunctival Hemorrhage Score |
0; 0 | 0.682 |
Summary
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .
Additionally, the study will also seek to track:
1. The total number of pills each patients consume from the prescribed 5 day regimen.
2. Any associated side effects.
3. Additional pain medications prescribed in case of inadequate pain control, postoperatively.
Eligibility Criteria
Inclusion Criteria
- Minimum age of 18 years
- Able to speak and understand english.
- Undergoing rhinoplasty for cosmetic purposes
- Undergoing rhinoplasty for treatment of nasal obstruction
Exclusion Criteria
- Less than 18 years of age
- Cannot speak and understand english
- Patients who have undergone nasal surgery in the past
- Patients not undergoing nasal surgery
- Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center.
- Patients with any known allergies to the class of pain medications used in the study.
Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - 3223 to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.
Data sourced from ClinicalTrials.gov (NCT03584152). 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.