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Clinical Trials/NCT04219397
NCT04219397
Completed
Not Applicable

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

Indiana University2 sites in 1 country83 target enrollmentJanuary 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use, Unspecified
Sponsor
Indiana University
Enrollment
83
Locations
2
Primary Endpoint
Assess participation in medication take back through follow up phone interview questionnaire.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 23, 2020
End Date
January 3, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: Post-discharge days 8-10

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

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

Time Frame: Post-discharge days 8-10

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

Quantification of residual opioids.

Time Frame: Post-discharge days 8-10

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

Secondary Outcomes

  • Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.(Post-discharge days 8-10)
  • Frequency of opioid consumption through follow up phone interview questionnaire.(Post-operative day 1 through post-discharge day 10)
  • Average daily pain scores reported as values on Numerical Rating Scale.(Preoperatively through post-discharge day #10)

Study Sites (2)

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