Opioid Laws and Pediatric Use

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04543227

Collaborator

Ohio Department of Public Safety (Other)

400

Enrollment

Location

27.6

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Burns Knee Injuries Opioid Use Pain	Behavioral: Opioid Use 90-Days Post Treatment

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 10, 2020

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in opioid prescriptions [2 years before and 2 years after Ohio opioid law]
Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses)
Long-term opioid use [90 days post treatment]
Patients using opioid medications 90-days post treatment

Secondary Outcome Measures

Comparison of opioid medications usage [2 years before and 2 years after Ohio opioid law]
Comparison of opioid medications prescribed by injury type (burn and knee arthroscopy)

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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