Using melatonin to improve recovery in teens after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the feasibility and acceptability of melatonin in promoting healthy sleep for adolescents undergoing major musculoskeletal surgery. A total of 45 participants aged 12-18 will be enrolled and randomized to receive either melatonin or a placebo, alongside sleep hygiene instructions. Participants will wear an actigraphy device and complete daily check-in surveys and online assessments over a four-month period to measure outcomes related to sleep, pain, and health-related quality of life. The study will assess both short-term and long-term effects of melatonin on recovery.

Why it matters

Who can join: the full rules

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

Where it's running

• Lucile Packard Children's Hospital
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Jennifer A Rabbitts, M.B.Ch.B.
• Email: surgerysmart@stanford.edu
• Phone: (650) 427-0187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.