Clinical trial NCT04543227: Opioid Laws and Pediatric Use
Official title: The Impact of Ohio's Opioid Prescriptions Law on Opioid Use and Outcomes in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Knee Injuries
Opioid Use
Pain
Keywords: Burns
Knee Arthroscopy
Opioid
Pain
Chronic
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio Department of Public Safety
First posted: 2020-09-10
Enrollment: 980
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in opioid prescriptions
timeFrame: 2 years before and 2 years after Ohio opioid law
measure: Long-term opioid use
timeFrame: 90 days post treatment
Secondary outcomes:
measure: Comparison of opioid medications usage
timeFrame: 2 years before and 2 years after Ohio opioid law
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Henry Xiang, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.