Opioid Laws and Pediatric Use

NCT04543227 | Completed

• 1 other identifier: STUDY00001192
• Study Type: observational
• Target: 980
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Knee Injuries; Opioid Use; Pain

Keywords

Burns; Knee Arthroscopy; Opioid; Pain; Chronic

Outcome Measures

Primary Outcomes (2)

• 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

• Long-term opioid use

  Patients using opioid medications 90-days post treatment

  90 days post treatment

Secondary Outcomes (1)

• Comparison of opioid medications usage

  2 years before and 2 years after Ohio opioid law

Study Arms (4)

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

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

Interventions

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

Prospective Burn Injuries; Prospective Knee Arthroscopy

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Ohio Department of Public Safety: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Armstrong M, Groner JI, Samora J, Olbrecht VA, Tram NK, Noffsinger D, Boyer EW, Xiang H. Impact of opioid law on prescriptions and satisfaction of pediatric burn and orthopedic patients: An epidemiologic study. PLoS One. 2023 Nov 16;18(11):e0294279. doi: 10.1371/journal.pone.0294279. eCollection 2023.

  PMID: 37972014 RESULT

MeSH Terms

Conditions

Burns; Knee Injuries; Pain; Bronchiolitis Obliterans Syndrome

Interventions

Aftercare

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Henry Xiang, MD, MPH, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Center Director

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: September 10, 2020
• Primary Completion: June 30, 2022
• Study Completion: November 16, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)