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

NCT03575377 | Completed

• 1 other identifier: IRB18-00157
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillitis; Sleep Disordered Breathing; Hernia; Hydrocele; Hypospadias; Undescended Testicle; Circumcision

Outcome Measures

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.

  2-4 weeks

Secondary Outcomes (5)

• Quantity of opioid used after surgery

  2-4 weeks

• Quantity of opioid leftover after surgery

  2-4 weeks

• Proper storage of opioids

  2-4 weeks

• Barriers to opioid disposal

  2-4 weeks

• Disposal of unused opioids by any method

  2-4 weeks

Study Arms (2)

Deterra Bag

EXPERIMENTAL

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

Other: Disposal Aid

Control

NO INTERVENTION

These families will receive routine postoperative instructions only.

Interventions

Disposal Aid OTHER

Deterra® drug deactivation system

Deterra Bag

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Ohio State University: collaborator

Study Sites (1)

Jennifer Cooper

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 31233129 DERIVED

MeSH Terms

Conditions

Tonsillitis; Sleep Apnea Syndromes; Hernia; Testicular Hydrocele; Hypospadias; Cryptorchidism

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Penile Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jennifer Cooper, PhD

  Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 2, 2018
• Study Start: June 7, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)