Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04950660
Eligibility Criteria:
Inclusion Criteria:
* must meet criteria for surgical correction of scoliosis
* must be able to swallow pills
* must have English as a primary language
* must possess mental capacity to understand purpose of the study
* patient must carry diagnosis of adolescent idiopathic scoliosis
* surgery must be performed via posterior approach
* operation performed by either Dr. John T. Anderson, Dr. Richard M. Schwend, Dr. Aaron Shaw, Dr. Michael Benvenuti
* post-surgical AIS patients from June 2019-June 2024
* the patient must be between the ages of 12 and 17 years old
* the patient and one of their biological parents or guardian(s) must give consent for patient to be included in this study
* Negative Suicide screen
Exclusion Criteria:
* obesity, as defined by a BMI at or above the 95th percentile
* weight below 40 kg
* any orthopedic diagnosis other than AIS
* revision spine surgery
* anterior or combined approach
* admission to PICU post-op
* use of Oxycodone post-op
* allergies to ibuprofen, caffeine, codeine, or diazepam
* history of renal disease
* history of a coagulation disorder
* history of cardiac dysrhythmia or open heart surgery
* history of Chronic Pain Syndrome or Complex Regional Pain Syndrome
* current use of oral central nervous system stimulant (e.g. methylphenidate)
* Positive Suicide screen
The following populations will be excluded:
* Children over the age of 18, or turning 18 during time of surgical treatment
* Children or parents unable to consent
* Individuals with cognitive delays
* Pregnant females
* Prisoners
* Wards of the state
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT04950660
Study Brief:
Protocol Section:
NCT04950660