Opioid Laws and Pediatric Use

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543227
• Other study ID #: STUDY00001192
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: November 16, 2023

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: November 16, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Knee Injuries
• Opioid Use
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Ohio Department of Public Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Long-term opioid use	Patients using opioid medications 90-days post treatment	90 days post treatment
Secondary	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