Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-03-17
Study Completion Date
2029-01-31
Brief Summary
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The study purpose is to document the typical trajectory of perioperative pain experience in Cerebral Palsy (CP) and to identify important predictive factors for the development of chronic postsurgical pain. The main aims of the investigators are to:
1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
2. Identify predictors for CPSP in children with CP and develop an applicable risk index.
3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.
Participants will complete:
1. Questionnaires/Surveys via email and text message
2. In-person Sensory Tests
3. In-person Gait and Motion Analysis
1. Quantify the trajectory of pain and opioid use in the context of orthopedic surgery in children with CP.
2. Identify predictors for CPSP in children with CP and develop an applicable risk index.
3. Examine relationships between perioperative pain severity and functional/mobility outcomes achieved by orthopedic surgery in children with CP.
Participants will complete:
1. Questionnaires/Surveys via email and text message
2. In-person Sensory Tests
3. In-person Gait and Motion Analysis
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Detailed Description
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Conditions
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Cerebral Palsy
Chronic Post Surgical Pain
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* CP diagnosis
* Have a scheduled lower extremity or spine orthopedic surgery
* Have a scheduled lower extremity or spine orthopedic surgery
Exclusion Criteria
* Non-English speaking and reading parent/guardian
Minimum Eligible Age
5 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
University of Minnesota
OTHER
Sponsor Role
collaborator
Nemours Children's Hospital
OTHER
Sponsor Role
collaborator
Chantel Burkitt
OTHER
Sponsor Role
lead
Responsible Party
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Chantel Burkitt
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Chantel Burkitt, PhD
Role: PRINCIPAL_INVESTIGATOR
Gillette Children's, University of Minnesota
Locations
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Nemour's Children's Hospital
Wilmington, Delaware, United States
Site Status
RECRUITING
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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STUDY00014668
Identifier Type: -
Identifier Source: org_study_id
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