The Influence of Perioperative Sleep Quality on Postoperative Pain Outcomes in Pediatric Patients Undergoing Knee Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Difference in opioid consumption between self-report and eCap
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •able to read, understand, and speak English
- •are undergoing posterior spinal fusion surgery
- •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
Arms & Interventions
PSF
Pediatric subjects undergoing posterior spinal fusion (PSF) surgery for idiopathic scoliosis.
Intervention: eCAP (Device)
Outcomes
Primary Outcomes
Difference in opioid consumption between self-report and eCap
Time Frame: Days 1-14 post-op
The eCAP Electronic Content Monitor (ECM) is a smart pill bottle used to monitor and improve medication adherence. When opened, an event is recorded, and the data is securely stored. The eCAP device timestamps medication usage and provides a visualization demonstrating how patients are taking medications, providing robust analytics. Subjects will also record each time they take an opioid pain medicine on a daily diary.
Pittsburgh Sleep Quality Index
Time Frame: Baseline
Pittsburgh Sleep Quality Index (PSQI) is a validated, self-report questionnaire that assesses sleep quality over a one-month period that takes five to ten minutes to complete. It offers seven component scores (e.g., subjective sleep quality, latency, duration, and efficiency) as well as a composite score that measures overall sleep quality. A total score greater than five yields a sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p \<0.001) in distinguishing good from poor sleepers.
Secondary Outcomes
No secondary outcomes reported
Investigators
Grant Heydinger
Assistant Professor of Anesthesiology
Nationwide Children's Hospital