Studying Melatonin and Recovery in Teens (SurgerySMART)
Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence
About this trial
This is an interventional other trial for Juvenile; Scoliosis focused on measuring sleep, pain medicine, pediatric pain medicine, melatonin, pilot feasibility trial, acute pain, chronic pain, CPSP, chronic postsurgical pain, spinal fusion surgery, adolescent, perioperative melatonin
Eligibility Criteria
Inclusion Criteria: Patients/youth: Age 12-18 years Participants undergoing elective spinal fusion surgery for eligible conditions California state resident Regular access to internet and smartphone Can read and understand English Parents/caregivers Biological parent or legal guardian of youth Can read and understand English Exclusion Criteria: Patients/youth Prescription medication for premorbid insomnia Cognitive impairment or developmental delay Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication High risk for sleep related breathing disorder Chronic medical condition that is severe/systemic or requires regular treatment regimen Psychiatric admission in prior 30 days Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery BMI ≥ 99th percentile Enrollment in another therapeutic study Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient's participation in the study
Sites / Locations
- Lucile Packard Children's Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
5mg Liquid Placebo
5mg Liquid Melatonin
Participants will take a placebo of 5mg syrup, complete surveys, and wear an actigraphy device during the specified study period.
Participants will take 5mg of melatonin in liquid form, complete surveys, and wear an actigraphy device during the specified study period.