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Inadequate resources to start the study at this site.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | 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. |
|
| Vicodin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicodin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Study enrollment rate of eligible participants | The proportion of patients that provide consent for the study | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherif Said, BDS | BU Goldman School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry M. Goldman School of Dental Medicine | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C083640 | acetaminophen, hydrocodone drug combination |
| D003907 | Dexamethasone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug | 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. |
|
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| Medications taken for breakthrough pain | evening of the surgery, the day after the surgery and one week after the surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |