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

Indiana University

Status: Completed

Conditions: Opioid Use, Unspecified

Treatments: Other: Medication take back; Other: Medication home disposal

Study type: Interventional

Funder types: Other

Identifiers

NCT04219397

1905175369

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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83 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Medication take back

Home disposal kit intervention

Experimental group

Description:

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.

Treatment:

Other: Medication home disposal