Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
NCT ID: NCT04008043
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2020-02-29
2021-05-31
Brief Summary
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Secondary objectives include:
To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.
To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.
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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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Dexamethasone
Participants in this arm will take a 6mg dexamethasone tablet the day before surgery, a 6 mg tablet the day of surgery, a 4mg tablet the day after surgery and a 2mg tablet the second day after surgery. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Dexamethasone
In addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Vicodin
Participants in this arm will take a vicodin tablet every 4-6 hrs as needed to a maximum of 8 tablets after surgery. Each tablet has 300 mg acetaminophen and 5 mg hydrocodone. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Vicodin
In addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Interventions
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Vicodin
In addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Dexamethasone
In addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be aged 21 years old and above
* Able and willing to provide informed consent
* 20 non-obese patients with BMI less than 30kg/m2
* 20 obese patients with BMI greater than or equal to 30kg/m2
* Diabetic and hypertensive patients included
Exclusion Criteria
* Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month
* Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history
* Patients with kidney dysfunction
* Patients at risk for infective endocarditis determined by the medical history or past medical records
21 Years
ALL
No
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Sherif Said, BDS
Role: PRINCIPAL_INVESTIGATOR
BU Goldman School of Dental Medicine
Locations
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Henry M. Goldman School of Dental Medicine
Boston, Massachusetts, United States
Countries
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Other Identifiers
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H-38061
Identifier Type: -
Identifier Source: org_study_id
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