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OpenTrials
Completed

NCT Number: NCT04543227

Opioid Laws and Pediatric Use

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.

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Key information

Conditions

Burns Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Knee Injuries Leg Injuries Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Opioid Use Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Wounds and Injuries

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Use 90-Days Post Treatment

Behavioral

Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain

Primary outcomes

  1. 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. Long-term opioid use

    Time frame: 90 days post treatment

    Patients using opioid medications 90-days post treatment

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Ohio Department of Public Safety

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 10, 2020
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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