Hernia Clinical Trial
Official title:
Opioid Use, Storage, and Disposal Among Pediatric Patients After Surgery
Verified date | March 2019 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Opioids are an important component of post-operative pain management among children, but are often prescribed in excess and rarely disposed of appropriately. The lack of prompt and proper opioid disposal after recovery from surgery is contributing to the opioid crisis in Ohio by placing children at risk of accidental ingestion of opioids remaining in the home and allowing for unused opioids to be diverted for non-medical use. The investigators propose to reduce the burden of the opioid crisis in Ohio by testing a strategy to increase proper opioid disposal by families of children undergoing outpatient surgery. The investigators will test the impact of a novel opioid disposal mechanism, the Deterra® drug deactivation system, after pediatric surgical operations. This system deactivates pills, liquids, or patches, allowing for their disposal in the home garbage. The investigators propose to evaluate the effectiveness of providing Deterra® bags to families of children having surgery on their disposal of excess opioids. The investigators will perform a randomized controlled trial (RCT) to test the effectiveness of Deterra® to improve opioid disposal among families of children having outpatient surgery at Nationwide Children's Hospital.
Status | Completed |
Enrollment | 202 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility |
Inclusion Criteria: - Parent or legal guardian of a child having outpatient otolaryngologic or urologic surgery at Nationwide Children's Hospital - Child's age is between 1 and 17 years - Child is expected to receive a discharge opioid prescription Exclusion Criteria: •Unable or unwilling to track pain medication use or complete a follow-up survey |
Country | Name | City | State |
---|---|---|---|
United States | Jennifer Cooper | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Nationwide Children's Hospital | Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proper disposal of unused opioids | The proper disposal of unused opioids, defined as the disposal of unused opioids by an FDA-recommended method or by using the Deterra® drug deactivation system. | 2-4 weeks | |
Secondary | Quantity of opioid used after surgery | Number of doses of opioid pain medication used after surgery | 2-4 weeks | |
Secondary | Quantity of opioid leftover after surgery | Number of doses of opioid pain medication leftover after surgery | 2-4 weeks | |
Secondary | Proper storage of opioids | Whether the opioids were properly stored after surgery | 2-4 weeks | |
Secondary | Barriers to opioid disposal | What the parent/caregiver perceived as barriers to their disposal of their child's opioids after surgery | 2-4 weeks | |
Secondary | Disposal of unused opioids by any method | Disposal of unused opioids by any recommended or non-recommended method | 2-4 weeks |
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