Studying Melatonin and Recovery in Teens

Official title

SurgerySMART: Studying Melatonin and Recovery in Teens

Overview

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.

Detailed description

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.

Interventions

• Dietary supplement Fast-Dissolve Melatonin Pill
  Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
• Other Fast-Dissolve Placebo Pill
  Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.

Primary outcome measures

• Treatment Adherence [Time frame: Treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)]
• Study Acceptability [Time frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)]
• Enrollment and Retention [Time frame: Pre-treatment (T1), treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)]
• Treatment Side Effects [Time frame: Assessed one time at Day 21 post-op, and at 3-month follow-up (T3)]

Secondary outcome measures (6)

• Change in Sleep Quality [Time frame: Pre-treatment (T1) and one time at 3-month follow-up (T3)]
• Change in Peri-operative Sleep Quality [Time frame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)]
• Change in Sleep Duration [Time frame: Treatment phase of 14 days before surgery through 21 days post-op (T2) and 7 days at 3-month follow-up (T3)]
• Change in Health-related Quality of Life [Time frame: Pre-treatment (T1) and one time at 3-month follow-up (T3)]
• Change in Global Pain Severity [Time frame: Pre-treatment (T1), one time at Day 21 post-op (T2), and one time at 3-month follow-up (T3)]
• Change in Pain Intensity and Interference [Time frame: Baseline pre-surgery assessment (T1), treatment phase of 14 days before surgery through 21 days after surgery (T2), and 7 days at 3-month follow-up (T3)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

United States · 1 center

• Lucile Packard Children's Hospital — Palo Alto

Publications

• Haack M, Simpson N, Sethna N, Kaur S, Mullington J. Sleep deficiency and chronic pain: potential underlying mechanisms and clinical implications. Neuropsychopharmacology. 2020 Jan;45(1):205-216. doi: 10.1038/s41386-019-0439-z. Epub 2019 Jun 17. PMID 31207606
• Moore S, Stockbridge L. Fresnel prisms in the management of combined horizontal and vertical strabismus. Am Orthopt J. 1972;22:14-21. No abstract available. PMID 5052847
• Nabavi SM, Nabavi SF, Sureda A, Xiao J, Dehpour AR, Shirooie S, Silva AS, Baldi A, Khan H, Daglia M. Anti-inflammatory effects of Melatonin: A mechanistic review. Crit Rev Food Sci Nutr. 2019;59(sup1):S4-S16. doi: 10.1080/10408398.2018.1487927. Epub 2019 Mar 21. PMID 29902071
• Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3. PMID 33319916
• Yousaf F, Seet E, Venkatraghavan L, Abrishami A, Chung F. Efficacy and safety of melatonin as an anxiolytic and analgesic in the perioperative period: a qualitative systematic review of randomized trials. Anesthesiology. 2010 Oct;113(4):968-76. doi: 10.1097/ALN.0b013e3181e7d626. PMID 20823763
• Andersen LP, Werner MU, Rosenberg J, Gogenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014 Oct;69(10):1163-71. doi: 10.1111/anae.12717. Epub 2014 May 19. PMID 24835540
• Caumo W, Torres F, Moreira NL Jr, Auzani JA, Monteiro CA, Londero G, Ribeiro DF, Hidalgo MP. The clinical impact of preoperative melatonin on postoperative outcomes in patients undergoing abdominal hysterectomy. Anesth Analg. 2007 Nov;105(5):1263-71, table of contents. doi: 10.1213/01.ane.0000282834.78456.90. PMID 17959953
• Caumo W, Levandovski R, Hidalgo MP. Preoperative anxiolytic effect of melatonin and clonidine on postoperative pain and morphine consumption in patients undergoing abdominal hysterectomy: a double-blind, randomized, placebo-controlled study. J Pain. 2009 Jan;10(1):100-8. doi: 10.1016/j.jpain.2008.08.007. Epub 2008 Nov 17. PMID 19010741

Identifiers

NCT: NCT06093477 · IRB-71745 · 7K24AR080786-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗