Opioid Use, Storage, and Disposal Among Pediatric Patients After Surgery

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 Deterra® for opioid disposal among families of Ohio children having surgery.
The investigators will perform a randomized controlled trial (RCT) to test the effectiveness
of Deterra® to improve proper opioid disposal among families of children having outpatient
surgery at Nationwide Children's Hospital.

The goal of this project is to evaluate the impact of providing the Deterra® drug
deactivation system on the excess opioid disposal rate among families of children having
outpatient otolaryngologic or urologic surgery at NCH. A second objective of this study is to
evaluate whether the impact of the Deterra® drug deactivation system varies by
parent/guardian health literacy level or signing of an "opioid consent form" acknowledging
that they will follow appropriate dosing recommendations, not give opioids if their child
appears sleepy, not give Tylenol concurrently with Tylenol-containing opioid medications,
dispose of unused opioids safely and responsibly, and contact their child's surgeon's office
or the on-call physician with any questions. To accomplish these objectives, the
investigators will perform a randomized controlled trial comparing groups of patients who
receive either 1) a Deterra® bag along with brief instruction on how and why to use it along
with routine postoperative instructions or 2) routine postoperative instructions.

The investigators plan to enroll 202 caregivers of children having outpatient surgery. All
families will receive a 1-page pain journal to record the child's opioid and non-opioid
adjunct pain medication administration. In addition to the instructions provided by the care
team as described above, families randomized to the intervention arm will additionally
receive a Deterra® bag and instructions on its use by a research team member.

In order to minimize disruption to the clinical work flow, minimal data will be collected at
baseline directly from enrolled families. This will include the contact information required
for follow-up, a limited set of research related questions, and a brief assessment of
parent/guardian health literacy. Baseline demographic and clinical characteristics of the
child, such as their primary payer, residential address, age, and comorbidities at the time
of surgery will be extracted from the electronic medical record.

Parents/guardians will be contacted by their preferred method of email survey or phone call
at 2 weeks postoperatively, at which time they will be surveyed on their child's
postoperative opioid and non-opioid medication use, opioid storage location, quantity of
opioid remaining, disposal method, and any barriers to disposal. If the child continues to
require opioids, they will be contacted again at 4 weeks postoperatively. If the parent
believes that their older child or adolescent can assist in answering the survey questions,
they will be encouraged to complete the survey together. The primary outcome of this trial is
the proper disposal of unused opioids. Secondary outcomes include the quantities of opioid
used and leftover after surgery, opioid storage location, disposal by any method, and
barriers to disposal.

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