Trial Outcomes & Findings for Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery (NCT NCT03285061)
NCT ID: NCT03285061
Last Updated: 2021-01-06
Results Overview
Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
Standard Disposal Instructions
These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
|
At Home Disposal
With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Disposal Instructions
n=37 Participants
These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
|
At Home Disposal
n=38 Participants
With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=37 Participants
|
36 Participants
n=38 Participants
|
70 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=37 Participants
|
2 Participants
n=38 Participants
|
5 Participants
n=75 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=37 Participants
|
27 Participants
n=38 Participants
|
51 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
11 Participants
n=38 Participants
|
24 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: These two populations constitute a subgroup of all patients initially enrolled in the study. Specifically, these two populations constitute those patients that had leftover medications (as opposed to all patients who were enrolled in the trial). For this reason, these numbers are disparate from those of the Results Participant Flow.
Patients will be given a survey to obtain their method of disposal for excess post-operative pain medication.
Outcome measures
| Measure |
Standard Disposal Instructions
n=21 Participants
These patients will receive standard instructions on proper disposal of excess pain medication following orthopedic foot and ankle surgery. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
|
At Home Disposal
n=26 Participants
With patients' prescription for post operative pain medication, a Deterra portable drug deactivation system will be provided, along with instructions on proper use. They will be asked complete a survey at their 6 post operative follow-up on excess medication disposal.
Deterra Drug Deactivation System: A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.
|
|---|---|---|
|
Number of Participants Who Safely Disposed The Excess Medication
|
8 Participants
|
22 Participants
|
Adverse Events
Standard Disposal Instructions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
At Home Disposal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place