Opioid Laws and Pediatric Use

April 29, 2024 updated by: Henry Xiang, Nationwide Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

980

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients (age 0-18 years) treated at our institution for either a burn injury or knee arthroscopy procedure and received an opioid prescription.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in opioid prescriptions
Time Frame: 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)
2 years before and 2 years after Ohio opioid law
Long-term opioid use
Time Frame: 90 days post treatment
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
Time Frame: 2 years before and 2 years after Ohio opioid law
Comparison of opioid medications prescribed by injury type (burn and knee arthroscopy)
2 years before and 2 years after Ohio opioid law

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

Ohio Department of Public Safety

Investigators

  • Principal Investigator: Henry Xiang, MD, MPH, PhD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

November 16, 2023

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Opioid Use 90-Days Post Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe