Oral Surgery
Conditions
Keywords
Dexamethasone, Vicodin, Pain management
Brief summary
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.
Interventions
DRUGVicodin
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.
DRUGDexamethasone
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.
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study enrollment rate of eligible participants | 12 months | The proportion of patients that provide consent for the study |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed