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Completed

NCT Number: NCT04219397

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

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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Key information

Conditions

Opioid Use, Unspecified

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children/Indiana University, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication take back

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.

Medication home disposal

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.

Primary outcomes

  1. 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?

  2. 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.

  3. 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.

Secondary outcomes

  1. Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.

    Time frame: Post-discharge days 8-10

    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.

  2. Average daily pain scores reported as values on Numerical Rating Scale.

    Time frame: Preoperatively through post-discharge day #10

    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.

  3. Frequency of opioid consumption through follow up phone interview questionnaire.

    Time frame: Post-operative day 1 through post-discharge day 10

    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.

Other outcomes

  1. Demographic data

    Time frame: preoperatively through post-discharge day 10

    Obtain demographic data for study participants including: age, sex, race, ethnicity, and zip code as a marker of socioeconomic status, household income levels

  2. Post operative pain scores reported as a numerical value on the Numerical Rating Scale.

    Time frame: Post operative day zero through post-discharge day 10

    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.

  3. Opioid consumption

    Time frame: Preoperatively through post-discharge day 10

    Assess total daily morphine equivalents

  4. Prescription fill

    Time frame: Post discharge day 10

    Assess if the patient's prescription for oxycodone was filled

  5. Actions related to residual opioids

    Time frame: Post discharge day 10

    Obtain qualitative information regarding the patient/families' intentions for what to do with left over opioid medications if they exist

  6. Motivations for disposal of residual opioids obtained through study specific follow up phone call questionnaire.

    Time frame: Post discharge day 10

    Assess patient/family motivations for disposal of any residual opioids following completion of analgesic therapy.

  7. Motivations for retention of residual opioids through study specific follow up phone interview questionnaire.

    Time frame: Post discharge day 10

    Assess patient/family motivations for retention of any residual opioids following completion of analgesic therapy

  8. Barriers to disposal of residual opioids through study specific follow up phone interview questionnaire.

    Time frame: Post discharge day 10

    Assess patient/family barriers, if any, to disposal of residual opioids following completion of analgesic therapy

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • LCMC Health
  • The Society for Pediatric Anesthesia

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2020
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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