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

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ClinicalTrials.gov Identifier: NCT03575377
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Jennifer Cooper, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Tonsillitis Sleep Disordered Breathing Hernia Hydrocele Hypospadias Undescended Testicle Circumcision Other: Disposal Aid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Opioid Use, Storage, and Disposal Among Pediatric Patients After Surgery
Actual Study Start Date : June 7, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
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
Deterra® drug deactivation system

No Intervention: Control
These families will receive routine postoperative instructions only.



Primary Outcome Measures :
  1. Proper disposal of unused opioids [ Time Frame: 2-4 weeks ]
    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.


Secondary Outcome Measures :
  1. Quantity of opioid used after surgery [ Time Frame: 2-4 weeks ]
    Number of doses of opioid pain medication used after surgery

  2. Quantity of opioid leftover after surgery [ Time Frame: 2-4 weeks ]
    Number of doses of opioid pain medication leftover after surgery

  3. Proper storage of opioids [ Time Frame: 2-4 weeks ]
    Whether the opioids were properly stored after surgery

  4. Barriers to opioid disposal [ Time Frame: 2-4 weeks ]
    What the parent/caregiver perceived as barriers to their disposal of their child's opioids after surgery

  5. Disposal of unused opioids by any method [ Time Frame: 2-4 weeks ]
    Disposal of unused opioids by any recommended or non-recommended method



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575377


Locations
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United States, Ohio
Jennifer Cooper
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Ohio State University
Investigators
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Principal Investigator: Jennifer Cooper, PhD Research Institute at Nationwide Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Cooper, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03575377     History of Changes
Other Study ID Numbers: IRB18-00157
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tonsillitis
Sleep Apnea Syndromes
Hypospadias
Cryptorchidism
Respiration Disorders
Respiratory Tract Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Testicular Diseases
Gonadal Disorders
Endocrine System Diseases