Opioid Laws and Pediatric Use

Study Overview
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Brief Summary
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The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. The overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after Ohio opioid prescription rules for acute pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days post-treatment.

Detailed Description
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This study has a prospective and retrospective component. Phase 1 involves a retrospective chart review will be performed among pediatric patients undergoing burn care or knee arthroscopy at our institution to determine a whether there was a reduction in prescribed opioid medications following the 2017 Ohio opioid prescription law. A 24-month pre-law period (August 1st, 2015, to August 31st, 2017) and 24-month post-law period (September 1st, 2017, to August 31st 2019) will be compared. This phase will include 300 patients (n=150 burn, n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods. Phase 2 involves a prospective patient telephone survey 90 days after burn care or knee arthroscopy procedure to assess the association of opioid prescribing, consumption and amount of left-over medications, and pain control status after 90 days. This phase will include 100 patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.

Official Title
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The Impact of Ohio's Opioid Prescriptions Law on Opioid Use and Outcomes in Pediatric Patients

Conditions
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Burns, Knee Injuries, Opioid Use, Pain

Intervention / Treatment
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* Behavioral: Opioid Use 90-Days Post Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients age 0-18 years (inclusive) treated at our institution for either a burn injury or knee arthroscopy procedure received at least one opioid prescription Exclusion Criteria: patients age 19 years and above patients who did not receive any opioid medications patients undergoing knee arthroscopy with simultaneous anterior cruciate ligament (ACL) reconstruction families unable to to communicate in English

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Burn Injuries<br>Pediatric patients treated at a large academic pediatric medical center for burn injuries between August 2015 - August 2019. | |
| Retrospective Knee Arthroscopy<br>Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure between August 2015 - August 2019. | |
| Prospective Burn Injuries<br>Pediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020. | Behavioral: Opioid Use 90-Days Post Treatment<br>* Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain<br>|
| Prospective Knee Arthroscopy<br>Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020. | Behavioral: Opioid Use 90-Days Post Treatment<br>* Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in opioid prescriptions | Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses) | 2 years before and 2 years after Ohio opioid law | 
| Long-term opioid use | Patients using opioid medications 90-days post treatment | 90 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of opioid medications usage | Comparison of opioid medications prescribed by injury type (burn and knee arthroscopy) | 2 years before and 2 years after Ohio opioid law | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Knee Arthroscopy, Opioid, Pain, Chronic