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Trials / Completed

CompletedNCT04543227

Opioid Laws and Pediatric Use

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

Status
Completed
Phase
Study type
Observational
Enrollment
980 (actual)
Sponsor
Nationwide Children's Hospital · Academic / Other
Sex
All
Age
0 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALOpioid Use 90-Days Post TreatmentSurvey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain

Timeline

Start date
2020-09-10
Primary completion
2022-06-30
Completion
2023-11-16
First posted
2020-09-10
Last updated
2024-04-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04543227. Inclusion in this directory is not an endorsement.

Opioid Laws and Pediatric Use (NCT04543227) · Clinical Trials Directory