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

Opioid Use, Unspecified Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219397
• Other study ID #: 1905175369
• Status: Completed
• Phase: N/A
• Start date: January 23, 2020
• Est. completion date: January 3, 2023

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use, Unspecified

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Riley Hospital for Children/Indiana University	Indianapolis	Indiana
United States	Children's Hospital of New Orleans/ LCMC Health	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	LCMC Health, The Society for Pediatric Anesthesia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Opioid consumption	Assess total daily morphine equivalents	Preoperatively through post-discharge day 10
Other	Prescription fill	Assess if the patient's prescription for oxycodone was filled	Post discharge day 10
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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