Trial Outcomes & Findings for Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes (NCT NCT02932579)
NCT ID: NCT02932579
Last Updated: 2022-03-16
Results Overview
To compare the pain control outcomes between a single-dose of pharmacogenomics- testing-driven-prescription of ibuprofen (400mg) or acetaminophen (650mg) with those of single-dose (standard of care) of combined formulation of hydrocodone and acetaminophen (5/650mg). A visual analog scale for dental pain will be used. Scale ranges from 0-100 with 100 worse pain.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
59 participants
Primary outcome timeframe
6 hours
Results posted on
2022-03-16
Participant Flow
Participant milestones
| Measure |
Standard of Care
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
|
Pharmacogenomic Group
Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
Ibuprofen: 400 mg
hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg
acetominophen: 650 mg
Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
26
|
|
Overall Study
COMPLETED
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
|
Pharmacogenomic Group
Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
Ibuprofen: 400 mg
hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg
acetominophen: 650 mg
Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Baseline characteristics by cohort
| Measure |
Standard of Care
n=33 Participants
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
|
Pharmacogenomic Group
n=26 Participants
Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
Ibuprofen: 400 mg
hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg
acetominophen: 650 mg
Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.0 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
24.9 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
26 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hoursPopulation: subjects completed the study
To compare the pain control outcomes between a single-dose of pharmacogenomics- testing-driven-prescription of ibuprofen (400mg) or acetaminophen (650mg) with those of single-dose (standard of care) of combined formulation of hydrocodone and acetaminophen (5/650mg). A visual analog scale for dental pain will be used. Scale ranges from 0-100 with 100 worse pain.
Outcome measures
| Measure |
Standard of Care
n=29 Participants
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
|
Pharmacogenomic Group
n=25 Participants
Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
Ibuprofen: 400 mg
hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg
acetominophen: 650 mg
Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
|
|---|---|---|
|
Mean Pain Score
|
41.9 units on a scale
Standard Deviation 24.8
|
28.9 units on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: subjects completed the study
To determine the number of patients who did not require prescribed opioid analgesic'rescue' after pharmacogenomic-guided acute postoperative dental pain management versus those taking the non-guided combined formulation of hydrocodone and acetaminophen.
Outcome measures
| Measure |
Standard of Care
n=29 Participants
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
|
Pharmacogenomic Group
n=25 Participants
Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
Ibuprofen: 400 mg
hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg
acetominophen: 650 mg
Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
|
|---|---|---|
|
Number of Participants That Did Not Need Opioid Analgesic Prescriptions
|
7 Participants
|
4 Participants
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Pharmacogenomic Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=29 participants at risk
Individuals within this group will receive standard of care for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
|
Pharmacogenomic Group
n=25 participants at risk
Individuals within this group will receive pharmacogenomic testing guided prescription of pain medication for postoperative dental pain secondary to extraction of impacted mandibular third molar(s)
Pharmacogenomic Testing: Saliva collection (5mL)
Ibuprofen: 400 mg
hydroxycontin/acetominophen: hydroxycontin 2.5 mg, acetominophen 325 mg
acetominophen: 650 mg
Oxycontin/acetominophen: 5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
34.5%
10/29 • Number of events 10 • 6 hours after dosing
any patient reported discomfort that may or may not be related to the medications during the 6 hour observation period
|
28.0%
7/25 • Number of events 7 • 6 hours after dosing
any patient reported discomfort that may or may not be related to the medications during the 6 hour observation period
|
Additional Information
Yanfang Ren, Professor
University of Rochester Eastman Institute for Oral Health
Phone: 5852735588
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place