Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
NCT ID: NCT05544734
Last Updated: 2023-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2022-11-10
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hydrocodone 5mg/acetaminophen 325mg
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
Hydrocodone 5Mg/Acetaminophen 325Mg Tab
5 mg/325 mg tablet
Acetaminophen 1000mg
1000 mg tablet
Ibuprofen 400 mg
400 mg tablet
Acetaminophen 1000mg + Ibuprofen 400mg
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
Acetaminophen 1000mg
1000 mg tablet
Ibuprofen 400 mg
400 mg tablet
Interventions
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Hydrocodone 5Mg/Acetaminophen 325Mg Tab
5 mg/325 mg tablet
Acetaminophen 1000mg
1000 mg tablet
Ibuprofen 400 mg
400 mg tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must understand and voluntarily sign an informed consent form
* Must be male or female and aged 18-95 years at time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria
* Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy
* Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain
* Subject has a history of opioid or alcohol use disorder
* Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease
* Subject has a history of severe constipation
* Subject is sensitive or allergic to any of the elements included in this study
* Subject is unable to complete the required pain dairy
* Subject is pregnant, planning pregnancy, or nursing
18 Years
95 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Shari Lipner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Medical College of Cornell University
New York, New York, United States
Countries
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References
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Hwang JK, Ricardo JW, Lipner SR. Combination of acetaminophen and ibuprofen is noninferior to acetaminophen and hydrocodone for postnail procedure analgesia: A randomized controlled trial. J Am Acad Dermatol. 2023 Dec;89(6):1300-1302. doi: 10.1016/j.jaad.2023.08.042. Epub 2023 Aug 22. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-10024054
Identifier Type: -
Identifier Source: org_study_id
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