Investigating Interventions to Reduce Residual Opioids in the Home Following Legitimate Opioid Prescribing in Children.

NCT04219397 | Completed

• 1 other identifier: 1905175369
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.

Conditions

Opioid Use, Unspecified

Keywords

opioid stewardship

Outcome Measures

Primary Outcomes (3)

• Quantification of residual opioids.

  Identify if there are left over opioid medications following completion of analgesic therapy, and if so, how many?

  Post-discharge days 8-10

• Assess participation in medication take back through follow up phone interview questionnaire.

  Assess the degree of participation in medication take back programs to dispose of any residual opioid medications following completion of analgesic therapy.

  Post-discharge days 8-10

• Assess participation in medication home disposal through follow up phone interview questionnaire.

  Assess the degree of participation in medication home disposal to dispose of any residual opioid medications following completion of analgesic therapy.

  Post-discharge days 8-10

Secondary Outcomes (3)

• Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.

  Post-discharge days 8-10

• Average daily pain scores reported as values on Numerical Rating Scale.

  Preoperatively through post-discharge day #10

• Frequency of opioid consumption through follow up phone interview questionnaire.

  Post-operative day 1 through post-discharge day 10

Other Outcomes (8)

• Demographic data

  preoperatively through post-discharge day 10

• Post operative pain scores reported as a numerical value on the Numerical Rating Scale.

  Post operative day zero through post-discharge day 10

• Opioid consumption

  Preoperatively through post-discharge day 10

Study Arms (3)

Control

NO INTERVENTION

Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol. There will be no interventions provided. They will receive a follow up phone call survey and be asked to return a completed medication education calendar that is provided as a part of usual APS care.

Medication take back education intervention

EXPERIMENTAL

Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive a standardized education intervention. This intervention will educate patients and their families about medication take back programs, and will provide tailored directions to the closest medication take back center from their home, and also an option for medication take back that is located in close proximity to Riley Hospital clinics.

Other: Medication take back

Home disposal kit intervention

EXPERIMENTAL

Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive standardized education about how to use the medication home disposal kit : Dispose Rx(r), and they will be instructed to use this kit to dispose of any left over opioid medications that they may have after they have competed therapy for pain management at home.

Other: Medication home disposal

Interventions

Medication take back OTHER

Patients will be provided with formal education about medication take back programs for left-over prescription medications. They will be provided with directions to the closest medication take back facility to their home, and directions to the closet medication take back facility near their post-operative clinic site, and instructed to dispose of any left-over oxycodone medication (at completion of analgesic therapy) through participating in medication take back.

Medication take back education intervention

Medication home disposal OTHER

Patients and their families will be provided with formal education about how to use the medication home disposal kit: Dispose Rx, provided with a Dispose Rx home disposal kit, and instructed to dispose of any left-over oxycodone prescription medications with this kit following completion of analgesic therapy.

Home disposal kit intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female children ages 12-17.9 years old
• ASA physical status 1 and 2
• Patients undergoing primary posterior spinal fusion surgery for correction of idiopathic scoliosis.
• Patients undergoing Nuss bar correction of pectus excavatum deformity.

You may not qualify if:

• Oxycodone allergy
• severe sleep apnea
• developmental delay
• neurological disorders
• liver disease/impairment
• renal disease/decreased renal function
• patients on opioid therapy prior to surgery
• Requires a translator for communication in English

Sponsors & Collaborators

• Indiana University: lead
• The Society for Pediatric Anesthesia: collaborator
• LCMC Health: collaborator

Study Sites (2)

Riley Hospital for Children/Indiana University

Indianapolis, Indiana, 46202, United States

Location

Children's Hospital of New Orleans/ LCMC Health

New Orleans, Louisiana, 70118, United States

Location

Study Officials

• Michele A Hendrickson, MD,MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Following patient enrollment, only the unblinded study coordinators will provide information and education to the patients/families about which arm they are randomized to. The investigator and other collaborators will conduct follow-up phone calls and data input and analysis in a blinded fashion.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Usual care (control) 2. Intervention #1: provision of formal education on medication take back 3. Intervention #2: provision of formal education on medication home disposal of residual opioids, and provision of a medication home disposal kit.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: January 7, 2020
• Study Start: January 23, 2020
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)