Studying Melatonin and Recovery in Teens

SurgerySMART: Studying Melatonin and Recovery in Teens

The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to:

1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions.
2. Wear a watch-like actigraphy device before and after surgery
3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery
4. Complete 10-20-minute online surveys 3 times over 4 months.

Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families.

The main aims are:

Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals.

Inclusion Criteria:

Patients/youth:

• Age 12-18 years
• Participants undergoing elective major musculoskeletal surgery for eligible conditions
• California state resident
• Regular access to internet and smartphone
• Can read and understand English or Spanish

Parents/caregivers

• Biological parent or legal guardian of youth
• Can read and understand English or Spanish

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