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Perioperative Sleep Quality and Postoperative Pain Outcomes

G

Grant Heydinger

Status

Invitation-only

Conditions

Surgery
ACL Injury
Pain
Sleep

Treatments

Device: eCAP

Study type

Observational

Funder types

Other

Identifiers

NCT06054802
STUDY00003629

Details and patient eligibility

About

This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.

Enrollment

166 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • able to read, understand, and speak English
  • are undergoing ACL repair or reconstruction
  • have availability of a mobile device/computer to receive text messages

Exclusion criteria

  • < 10 or > 18 years of age
  • have a history of sleep-disordered breathing including sleep apnea
  • have a history of chronic pain or current opioid use
  • have a history of developmental delay that would preclude study participation

Trial design

166 participants in 1 patient group

ACL surgery
Description:
Pediatric subjects undergoing surgery for ACL repair.
Treatment:
Device: eCAP

Trial contacts and locations

1

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Central trial contact

Catherine Roth, MPH; Julie Rice-Weimer, BSN

Data sourced from clinicaltrials.gov

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