About this trial
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.
Eligibility criteria
Qualifiers
Age 12-18 years
Participants undergoing elective major musculoskeletal surgery for eligible conditions
California state resident
Regular access to internet and smartphone
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fast-Dissolve Melatonin Pill
- Fast-Dissolve Placebo Pill
Treatment groups
Sponsors and collaborators
Stanford University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator