Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2019-08-09
2025-07-17
Brief Summary
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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.
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Detailed Description
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1. Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
2. If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
3. What are the common side effect profiles of the included drugs?
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Drug Arm A
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total
Norco 5Mg-325Mg Tablet
Opioid Analgesics
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.
Tylenol 325Mg Caplet
Non opioid analgesics
Ibuprofen 200 mg
Non opioid analgesics
Interventions
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Norco 5Mg-325Mg Tablet
Opioid Analgesics
Tylenol 325Mg Caplet
Non opioid analgesics
Ibuprofen 200 mg
Non opioid analgesics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to speak and understand english.
* Undergoing rhinoplasty for cosmetic purposes
* Undergoing rhinoplasty for treatment of nasal obstruction
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Sam P. Most
Chief, Division of Facial Plastic and Reconstructive Surgery
Principal Investigators
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SAM P Most, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Facial Plastic and Reconstructive Surgery Clinic
Stanford, California, United States
Countries
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References
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Johns MD. Transfer of a pattern versus component discrimination following training in a probabilistic situation. J Exp Psychol. 1965 Nov;70(5):506-9. doi: 10.1037/h0022535. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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46945
Identifier Type: -
Identifier Source: org_study_id
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