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Opioid Laws and Pediatric Use

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Nationwide Children's Hospital

Status

Completed

Conditions

Knee Injuries
Opioid Use
Burns
Pain

Treatments

Behavioral: Opioid Use 90-Days Post Treatment

Study type

Observational

Funder types

Other

Identifiers

NCT04543227
STUDY00001192

Details and patient eligibility

About

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.

Full 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.

Enrollment

980 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

980 participants in 4 patient groups

Retrospective Burn Injuries
Description:
Pediatric patients treated at a large academic pediatric medical center for burn injuries between August 2015 - August 2019.
Retrospective Knee Arthroscopy
Description:
Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure between August 2015 - August 2019.
Prospective Burn Injuries
Description:
Pediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020.
Treatment:
Behavioral: Opioid Use 90-Days Post Treatment
Prospective Knee Arthroscopy
Description:
Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020.
Treatment:
Behavioral: Opioid Use 90-Days Post Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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