Opioid Laws and Pediatric Use

Completed

• Conditions: Knee Injuries; Burns; Opioid Use; Pain
• Interventions: Behavioral: Opioid Use 90-Days Post Treatment

• Registration Number: NCT04543227
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study Start: 2020-09-10
• Study First Posted: 2020-09-10
• Primary Completion: 2022-06-30
• Study Completion: 2023-11-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 980

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Burn Injuries	Opioid Use 90-Days Post Treatment	Pediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020.
Prospective Knee Arthroscopy	Opioid Use 90-Days Post Treatment	Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States