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

Investigating the Impact of Formal Interventions on Reducing Residual Opioids in the Home Following Legitimate Prescribing for Acute Post-surgical Pain in Pediatric Patients.

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

Study Overview

• Status: Completed
• Conditions: Opioid Use, Unspecified
• Intervention / Treatment: Other: Medication take back; Other: Medication home disposal

Detailed Description

Prescription opioids are abused by an estimated 12.5 million Americans, and accidental opioid overdose is the leading cause of injury death in the US. Many of these drugs originate from leftover prescription opioids related to postoperative overprescribing, lack of proper disposal, and unsafe home storage. Governmental guidelines indicate that leftover prescription opioids should be preferentially returned to a drug take back site; however, many people do not utilize these programs due to travel distance, lack of transportation, or other factors.

The aims are to quantify the amount of unused opioids in the home following painful pediatric surgical procedures, investigate the impact of formal interventions on disposal of residual opioids in the home following these surgeries, and to identify current behaviors of adolescents and their family members in the handling of unused prescribed opioids.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children/Indiana University
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital of New Orleans/ LCMC Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Medication take back education intervention; 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; 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.
Experimental: Home disposal kit intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.	Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids despite formal education to patients/families about medication take back and medication home disposal of residual medications at the completion of analgesic therapy.	Post-discharge days 8-10
Average daily pain scores reported as values on Numerical Rating Scale.	Assess average daily pain scores for patients undergoing painful surgeries in the perioperative period and following discharge from the hospital. This will be obtained through numerical report on study specific calendar. Numerical values are reported as a minimum of zero and a maximum of 10 on the Numerical Rating Scale. 0 corresponds with no pain, 1 with lower pain, and 10 corresponds with the most severe pain.	Preoperatively through post-discharge day #10
Frequency of opioid consumption through follow up phone interview questionnaire.	Assess the frequency of daily oxycodone consumption and correlate consumption with self reported pain scores. This measure will ask for a self-reported numerical frequency of daily opioid medication use. When this medication is used, we ask patients to rate their pain on the Numerical rating Scale from 0 to 10. Zero corresponds with no pain, 10 corresponds with the most severe pain.	Post-operative day 1 through post-discharge day 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Obtain demographic data for study participants including: age, sex, race, ethnicity, and zip code as a marker of socioeconomic status, household income levels	preoperatively through post-discharge day 10
Post operative pain scores reported as a numerical value on the Numerical Rating Scale.	Obtain post operative pain scores from post operative day zero through post discharge day 10. Pain scores are obtained as a numerical value on the Numerical Rating Scale. A score of zero corresponds with no pain, 1 is low pain, and 10 is the most severe pain.	Post operative day zero through post-discharge day 10
Opioid consumption	Assess total daily morphine equivalents	Preoperatively through post-discharge day 10
Prescription fill	Assess if the patient's prescription for oxycodone was filled	Post discharge day 10
Actions related to residual opioids	Obtain qualitative information regarding the patient/families' intentions for what to do with left over opioid medications if they exist	Post discharge day 10
Motivations for disposal of residual opioids obtained through study specific follow up phone call questionnaire.	Assess patient/family motivations for disposal of any residual opioids following completion of analgesic therapy.	Post discharge day 10
Motivations for retention of residual opioids through study specific follow up phone interview questionnaire.	Assess patient/family motivations for retention of any residual opioids following completion of analgesic therapy	Post discharge day 10
Barriers to disposal of residual opioids through study specific follow up phone interview questionnaire.	Assess patient/family barriers, if any, to disposal of residual opioids following completion of analgesic therapy	Post discharge day 10

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: LCMC Health; The Society for Pediatric Anesthesia
• Investigators: Principal Investigator: Michele A Hendrickson, MD,MS, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: opioid stewardship
• Other Study ID Numbers: 1905175369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No