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The different patients responses to medications vary from dose effectiveness to adverse drug reaction (ADRs). ADRs affect outpatient settings as it account for estimated 1 million emergency department visits and over 3.5 million physician office visits per year. This subsequently results in about 125,000 hospital admissions. Currently, genetic testing conclude recommendation of dose adjustment or drug stop. However, further step is needed toward individually tailored prescription plan. The purpose of this study is to determine if the efficacy of the genetic testing (Pharmacogenomics) combined with the dietary habits and medications history to design an individually tailored prescription plan. This individualized-prescriptions will be tested if to reduce adverse drug reaction and improve pain management in periodontal surgeries. Hence, the current study will recruit subjects planned for two periodontal surgeries and evaluate pain management during and after periodontal surgery as well as post-surgical complication with and without individually tailored prescription plan. In addition, a comparison will be performed on number of drugs added, stopped or had a dose adjustment.
The objective of this study is to combine pharmacogenomics testing with social, dietary and medications history to formulate individualized-prescription plan and to test the effectiveness of this precession approach to reduce adverse drug reaction and improve pain management during and after periodontal surgeries.
The specific aims of the study are:
Self-controlled case series (SCCS) design will be used for the study. After eligibility has been ascertained and consent has been obtained, subjects planned for 2 surgeries will be enrolled in the study. First surgery will be carried out with the standard prescription for medications. For the second surgery, medications will be prescribed based on individualized assessment and pharmacogenomics report for each subject. These medications will be prescribed based on a consult with the periodontal surgeon's and PhamD investigators of the study. Medications that will be assessed in the study are: local anesthetics, IV sedation drugs and analgesics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Subject will receive standard prescription for local anesthetics, IV sedation drugs and analgesics at the time of first surgery. Subject will receive individually tailored-prescription for local anesthetics, IV sedation drugs and analgesics, based upon pharmacogenomic assessment at the time of second surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetics, IV sedation drugs and analgesics. | Drug | Personalized prescription for local anesthetics, IV sedation drugs and analgesics, based on pharmacogenomic assesment, social, dietary and medication history |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subject-reported post-surgery pain levels | Patient 's assessment of the pain on a scale of 0-10 in the first week after the surgery | Average of pain ratings, recorded after each surgery in the first week after the surgery. Patient will receive 1 call every 2 days to report his/her pain scale. Patient will receive a total of 3 calls in the 1st week after surgery. |
| Changes in post-surgery complications related to medications | Post-operative complication will be classified for 6 grades. | Post-operative complication will be assessed 2-4 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in post-surgery sedation assessment | Evaluated using Riker Sedation-Agitation Scale | Evaluated by the surgeon at the same day of the surgery where sedation performed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed El-Awady, BDS, MS, PhD | Dental College of Georgia-Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University-Dental College of Georgia | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |