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Opioid Laws and Pediatric Use

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04543227
Enrollment
980
Registered
2020-09-10
Start date
2020-09-10
Completion date
2023-11-16
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Knee Injuries, Opioid Use, Pain

Keywords

Burns, Knee Arthroscopy, Opioid, Pain, Chronic

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.

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.

Interventions

BEHAVIORALOpioid 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

Sponsors

Ohio Department of Public Safety
CollaboratorUNKNOWN
Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in opioid prescriptions2 years before and 2 years after Ohio opioid lawChange in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses)
Long-term opioid use90 days post treatmentPatients using opioid medications 90-days post treatment

Secondary

MeasureTime frameDescription
Comparison of opioid medications usage2 years before and 2 years after Ohio opioid lawComparison of opioid medications prescribed by injury type (burn and knee arthroscopy)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026