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CompletedNCT03575377Updated Mar 21, 2019

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

An interventional study of Disposal Aid in Tonsillitis, Sleep Disordered Breathing and Hernia, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
1 Year to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tonsillitis
  • Sleep Disordered Breathing
  • Hernia
  • Hydrocele
  • Hypospadias
  • Undescended Testicle
  • Circumcision
03

In context

Tonsillitis

103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.

This study's enrollment of 202 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.

Browse Tonsillitis studies →

Lead sponsor

Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

•Unable or unwilling to track pain medication use or complete a follow-up survey

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    Deterra Bag

    These families will receive a Deterra® bag (a drug Disposal Aid) and instructions on its use by a research team member.

    Other: Disposal Aid

  • No intervention
    Control

    These families will receive routine postoperative instructions only.

Interventions

  • OtherDisposal Aid

    Deterra® drug deactivation system

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2-4 weeks

Secondary outcomes

  1. Quantity of opioid used after surgery

    Number of doses of opioid pain medication used after surgery

    Time frame: 2-4 weeks

  2. Quantity of opioid leftover after surgery

    Number of doses of opioid pain medication leftover after surgery

    Time frame: 2-4 weeks

  3. Proper storage of opioids

    Whether the opioids were properly stored after surgery

    Time frame: 2-4 weeks

  4. Barriers to opioid disposal

    What the parent/caregiver perceived as barriers to their disposal of their child's opioids after surgery

    Time frame: 2-4 weeks

  5. Disposal of unused opioids by any method

    Disposal of unused opioids by any recommended or non-recommended method

    Time frame: 2-4 weeks

07

Study locations

1 site
  • Jennifer Cooper
    Columbus, Ohio 43205, United States
08

References and documents

Publications

  • Lawrence AE, Carsel AJ, Leonhart KL, Richards HW, Harbaugh CM, Waljee JF, McLeod DJ, Walz PC, Minneci PC, Deans KJ, Cooper JN. Effect of Drug Disposal Bag Provision on Proper Disposal of Unused Opioids by Families of Pediatric Surgical Patients: A Randomized Clinical Trial. JAMA Pediatr. 2019 Aug 1;173(8):e191695. doi: 10.1001/jamapediatrics.2019.1695. Epub 2019 Aug 5. PubMed 31233129 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03575377
Responsible party
Jennifer Cooper (Principal Investigator, Nationwide Children's Hospital) — Principal investigator
First posted
Jul 2, 2018
Start date
Jun 7, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Mar 21, 2019

Study contacts

Jennifer Cooper, PhD
principal investigator · Research Institute at Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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