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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:
From this study, the investigators hope to learn the following:
In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Arm A | Active Comparator | Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total |
|
| Drug Arm B | Active Comparator | Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norco 5Mg-325Mg Tablet | Drug | Opioid Analgesics |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) | Self reported pain intensity at every prescribed dose averaged over a period of 5 days. | 5 days post-operative [up to approximately 5 weeks post-baseline] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Drugs (Doses) Utilized | Use of any study medication, excluding tramadol. | 5 days |
| Number of Tramadol Doses Utilized | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| SAM P Most, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facial Plastic and Reconstructive Surgery Clinic | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29121158 | Background | Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034. |
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159 signed informed consent and 141 participants were randomized.
Participants were enrolled from the day of the pre-operative appointment (approximately 2 to 4 weeks prior to procedure) through post-operative day 7. Follow-up data at two time points (<6 months, and ≥ 6 months) were obtained by chart review.
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Arm A | Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total. |
| FG001 | Drug Arm B | Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Drug Arm A | Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total. |
| BG001 | Drug Arm B | Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) | Self reported pain intensity at every prescribed dose averaged over a period of 5 days. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | 5 days post-operative [up to approximately 5 weeks post-baseline] |
|
Up 4 weeks pre-procedure through post-operative follow-up (up to an average of 12 months following procedure)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug Arm A | Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam P. Most, MD, MBA | Stanford University | (650) 724-8019 | smost@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2018 | Nov 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2025 | Nov 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| C083640 | acetaminophen, hydrocodone drug combination |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Tylenol 325Mg Caplet | Drug | Non opioid analgesics |
|
|
| Ibuprofen 200 mg | Drug | Non opioid analgesics |
|
|
| Number Patients Who Reported Adequate Pain Control | 5 days |
| Side Effects of Pain Medications | Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events. | 5 days |
| Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. | Baseline and post-operative follow-up (up to an average of 12 months following procedure) |
| Visual Analog Scale-Functional (VAS-F) | Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. | Baseline and post-operative follow-up (up to an average of 12 months following procedure) |
| Visual Analog Scale-Aesthetic (VAS-A) | Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. | Baseline and post-operative follow-up (up to an average of 12 months following procedure) |
| Eyelid Edema Score | Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling. | Post-operative day 7 |
| Ecchymosis Score | Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis. | Post-operative day 7 |
| Subconjunctival Hemorrhage Score | Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage. | Post-operative day 7 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Study Drugs (Doses) Utilized | Use of any study medication, excluding tramadol. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | doses | 5 days |
|
|
|
|
| Secondary | Number of Tramadol Doses Utilized | Participants who completed the intervention. | Posted | Mean | Standard Deviation | doses | 5 days |
|
|
|
|
| Secondary | Number Patients Who Reported Adequate Pain Control | Participants who completed the intervention. | Posted | Count of Participants | Participants | 5 days |
|
|
|
|
| Secondary | Side Effects of Pain Medications | Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events. | Participants who completed the intervention. | Posted | Count of Participants | Participants | 5 days |
|
|
|
|
| Secondary | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and post-operative follow-up (up to an average of 12 months following procedure) |
|
|
|
|
| Secondary | Visual Analog Scale-Functional (VAS-F) | Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and post-operative follow-up (up to an average of 12 months following procedure) |
|
|
|
|
| Secondary | Visual Analog Scale-Aesthetic (VAS-A) | Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. | Participants who completed the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and post-operative follow-up (up to an average of 12 months following procedure) |
|
|
|
|
| Secondary | Eyelid Edema Score | Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | score on a scale | Post-operative day 7 |
|
|
|
|
| Secondary | Ecchymosis Score | Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | score on a scale | Post-operative day 7 |
|
|
|
|
| Secondary | Subconjunctival Hemorrhage Score | Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage. | Participants who completed the intervention. | Posted | Median | Inter-Quartile Range | score on a scale | Post-operative day 7 |
|
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Drug Arm B | Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. | 0 | 65 | 0 | 65 | 0 | 65 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| Constipation |
|
| Dizziness |
|
| Bleeding |
|
| Headache |
|
| Other |
|
| Fisher Exact |
| 0.001 |
The a priori threshold for statistical significance was < 0.05. |
| Other |
| Difference between-groups in constipation | Chi-squared | 0.571 | The a priori threshold for statistical significance was < 0.05. | Other |
| Difference between-groups in dizziness | Chi-squared | 0.078 | The a priori threshold for statistical significance was < 0.05. | Other |
| Difference between-groups in bleeding | Chi-squared | 0.724 | The a priori threshold for statistical significance was < 0.05. | Other |
| Difference between-groups in headache | Chi-squared | 0.795 | The a priori threshold for statistical significance was < 0.05. | Other |
| Difference between-groups in "other" side effects | Fisher Exact | 0.188 | The a priori threshold for statistical significance was < 0.05. | Other |
| SCHNOS-C (pre-operative) |
|
| Change in SCHNOS-C (post-operative) |
|
| t-test, 2 sided |
| 0.5267 |
The a priori threshold for statistical significance was < 0.05. |
| Other |