Clinical trial NCT04219397: Investigating Interventions to Reduce Residual Opioids in the Home Following Legitimate Opioid Prescribing in Children.
Official title: Investigating the Impact of Formal Interventions on Reducing Residual Opioids in the Home Following Legitimate Prescribing for Acute Post-surgical Pain in Pediatric Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use, Unspecified
Keywords: opioid stewardship
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: The Society for Pediatric Anesthesia
name: LCMC Health
First posted: 2020-01-07
Enrollment: 83
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of residual opioids.
timeFrame: Post-discharge days 8-10
measure: Assess participation in medication take back through follow up phone interview questionnaire.
timeFrame: Post-discharge days 8-10
measure: Assess participation in medication home disposal through follow up phone interview questionnaire.
timeFrame: Post-discharge days 8-10
Secondary outcomes:
measure: Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.
timeFrame: Post-discharge days 8-10
measure: Average daily pain scores reported as values on Numerical Rating Scale.
timeFrame: Preoperatively through post-discharge day #10
measure: Frequency of opioid consumption through follow up phone interview questionnaire.
timeFrame: Post-operative day 1 through post-discharge day 10
Other outcomes:
measure: Demographic data
timeFrame: preoperatively through post-discharge day 10
measure: Post operative pain scores reported as a numerical value on the Numerical Rating Scale.
timeFrame: Post operative day zero through post-discharge day 10
measure: Opioid consumption
timeFrame: Preoperatively through post-discharge day 10
measure: Prescription fill
timeFrame: Post discharge day 10
measure: Actions related to residual opioids
timeFrame: Post discharge day 10
measure: Motivations for disposal of residual opioids obtained through study specific follow up phone call questionnaire.
timeFrame: Post discharge day 10
measure: Motivations for retention of residual opioids through study specific follow up phone interview questionnaire.
timeFrame: Post discharge day 10
measure: Barriers to disposal of residual opioids through study specific follow up phone interview questionnaire.
timeFrame: Post discharge day 10
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children/Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans/ LCMC Health
state: Louisiana
Study officials:
affiliation: Indiana University
name: Michele A Hendrickson, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: