Opioid Use, Storage, and Disposal Among Pediatric Patients After Surgery
Condition: Tonsillitis; Sleep Disordered Breathing; Hernia; Hydrocele; Hypospadias; Undescended Testicle; Circumcision
MeSH terms: Tonsillitis; Sleep Apnea Syndromes; Hypospadias; Cryptorchidism
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Disposal Aid
Intervention type(s): Other
Intervention description(s): Deterra® drug deactivation system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention