Recruiting

Observational Study

Sponsor:

Chantel Burkitt

Code:

NCT05764681

Conditions

Cerebral Palsy

Chronic Post Surgical Pain

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Cerebral Palsy

Chronic Post Surgical Pain

Study ID

NCT05764681

Start date

Mar 17, 2023

Status verified date

Mar, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • CP diagnosis
  • Have a scheduled lower extremity or spine orthopedic surgery

Exclusion Criteria:

  • Non-English speaking and reading parent/guardian

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Brief Pain Inventory (BPI) score from 1 week preoperative to 1, 3, 6, and 12 months postoperative [ Time Frame: 1 month preoperative, and 1, 3, 6, and 12 months postoperative ]

Central Contacts and Locations

Central contacts

Maykala Owens

6512291717maykalajowens@gillettechildrens.com

Lisa Lykken

6512291768LisaALykken@gillettechildrens.com

Locations

Nemour's Children's Hospital

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Wade Shrader, MD

Wade.Shrader@nemours.org

Principal Investigator:

Wade Shrader, MD

Gillette Children's Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Chantel Burkitt, PhD

CBurkitt@gillettechildrens.com

Principal Investigator:

Chantel Burkitt, PhD

More Information

Sponsor

Chantel Burkitt

Last update posted

Sep 19, 2025

Last verified

Mar, 2025

Keywords

  • Cerebral Palsy
  • Pain
  • Chronic Pain
  • Post Surgical Pain
  • Orthopedic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Chantel Burkitt on 2025-09-19.