Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain

Study Overview
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Brief Summary
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The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study. 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.

Official Title
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The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study

Conditions
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Oral Surgery

Intervention / Treatment
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* Drug: Vicodin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be scheduled for periodontal surgery 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 allergic to any formulations used in the study 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>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. | Drug: Dexamethasone<br>* 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.<br>* Other names: corticosteroid;|
| Active Comparator: Vicodin<br>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. | Drug: Vicodin<br>* 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.<br>* Other names: acetaminophen and hydrocodone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study enrollment rate of eligible participants | The proportion of patients that provide consent for the study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with breakthrough pain |  | evening of the surgery, the day after the surgery and one week after the surgery | 
| Number medications taken for breakthrough pain |  | evening of the surgery, the day after the surgery and one week after the surgery | 
| Medications taken for breakthrough pain |  | evening of the surgery, the day after the surgery and one week after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vicodin, Dexamethasone, Pain management