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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2023-01-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Opioid Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Medication take back

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Medication home disposal

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes