Melatonin may boost teen recovery after spine or bone surgery
NCT ID NCT06093477
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether taking melatonin, a natural sleep aid, can help teens aged 12-18 sleep better and recover faster after major musculoskeletal surgery (like scoliosis or hip surgery). About 45 teens will receive either a fast-dissolve melatonin pill or a placebo daily. The main goal is to see if this approach is practical and acceptable, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Melatonin (dietary supplement)
- What this could lead to
- If it works, melatonin could become a simple, low-cost way to improve sleep and recovery for teens after major bone or spine surgery.
- What could go wrong
- This is a very small, early feasibility study with only 45 teens. It is designed to see if the idea is practical, not to prove it works. Melatonin is generally safe but may cause side effects like drowsiness or dizziness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lucile Packard Children's Hospital
RECRUITINGPalo Alto, California, 94304, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can 3D-printed guides tame the toughest spine screws?
- Which nerve block eases hip replacement pain better?
- Can augmented reality make spinal screws safer?
- Can a new bone graft match the gold standard for spinal fusion?