Investigating Interventions to Reduce Residual Opioids in the Home Following Legitimate Opioid Prescribing in Children.
- Conditions
- Opioid Use, Unspecified
- Interventions
- Other: Medication take backOther: Medication home disposal
- Registration Number
- NCT04219397
- Lead Sponsor
- Indiana University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medication take back education intervention Medication take back 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. Home disposal kit intervention Medication home disposal 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.
- Primary Outcome Measures
Name Time Method Assess participation in medication take back through follow up phone interview questionnaire. 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. 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. Post-discharge days 8-10 Identify if there are left over opioid medications following completion of analgesic therapy, and if so, how many?
- Secondary Outcome Measures
Name Time Method Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire. 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.
Frequency of opioid consumption through follow up phone interview questionnaire. 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.
Average daily pain scores reported as values on Numerical Rating Scale. 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.
Trial Locations
- Locations (2)
Riley Hospital for Children/Indiana University
🇺🇸Indianapolis, Indiana, United States
Children's Hospital of New Orleans/ LCMC Health
🇺🇸New Orleans, Louisiana, United States