Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-05-30
2028-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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3mg fast-dissolve pill
Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.
Fast-Dissolve Placebo Pill
Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.
3mg fast-dissolve pill (containing melatonin)
Participants will take 3mg in fast-dissolve pill form containing the active ingredient melatonin, complete surveys, and wear an actigraphy device during the specified study period.
Fast-Dissolve Melatonin Pill
Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
Interventions
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Fast-Dissolve Melatonin Pill
Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.
Fast-Dissolve Placebo Pill
Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.
Eligibility Criteria
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Inclusion Criteria
* 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
Parents/caregivers
* Biological parent or legal guardian of youth
* Can read and understand English
Exclusion Criteria
* 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
12 Years
18 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Stanford University
OTHER
Responsible Party
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Jennifer Rabbitts
Professor, Department of Anesthesiology, Perioperative, and Pain Medicine
Locations
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Lucile Packard Children's Hospital
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Barlow KM, Brooks BL, Esser MJ, Kirton A, Mikrogianakis A, Zemek RL, MacMaster FP, Nettel-Aguirre A, Yeates KO, Kirk V, Hutchison JS, Crawford S, Turley B, Cameron C, Hill MD, Samuel T, Buchhalter J, Richer L, Platt R, Boyd R, Dewey D. Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial. Pediatrics. 2020 Apr;145(4):e20192812. doi: 10.1542/peds.2019-2812. Epub 2020 Mar 26.
Buscemi N, Vandermeer B, Hooton N, Pandya R, Tjosvold L, Hartling L, Baker G, Klassen TP, Vohra S. The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen Intern Med. 2005 Dec;20(12):1151-8. doi: 10.1111/j.1525-1497.2005.0243.x.
Wei S, Smits MG, Tang X, Kuang L, Meng H, Ni S, Xiao M, Zhou X. Efficacy and safety of melatonin for sleep onset insomnia in children and adolescents: a meta-analysis of randomized controlled trials. Sleep Med. 2020 Apr;68:1-8. doi: 10.1016/j.sleep.2019.02.017. Epub 2019 Mar 9.
Smits MG, van Stel HF, van der Heijden K, Meijer AM, Coenen AM, Kerkhof GA. Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: a randomized placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2003 Nov;42(11):1286-93. doi: 10.1097/01.chi.0000085756.71002.86.
Smits MG, Nagtegaal EE, van der Heijden J, Coenen AM, Kerkhof GA. Melatonin for chronic sleep onset insomnia in children: a randomized placebo-controlled trial. J Child Neurol. 2001 Feb;16(2):86-92. doi: 10.1177/088307380101600204.
Karkela J, Vakkuri O, Kaukinen S, Huang WQ, Pasanen M. The influence of anaesthesia and surgery on the circadian rhythm of melatonin. Acta Anaesthesiol Scand. 2002 Jan;46(1):30-6. doi: 10.1034/j.1399-6576.2002.460106.x.
Rabbitts JA, Groenewald CB, Tai GG, Palermo TM. Presurgical psychosocial predictors of acute postsurgical pain and quality of life in children undergoing major surgery. J Pain. 2015 Mar;16(3):226-34. doi: 10.1016/j.jpain.2014.11.015. Epub 2014 Dec 22.
Groenewald CB, Beals-Erickson SE, Ralston-Wilson J, Rabbitts JA, Palermo TM. Complementary and Alternative Medicine Use by Children With Pain in the United States. Acad Pediatr. 2017 Sep-Oct;17(7):785-793. doi: 10.1016/j.acap.2017.02.008. Epub 2017 Feb 21.
Rabbitts JA, Kain Z. Perioperative Care for Adolescents Undergoing Major Surgery: A Biopsychosocial Conceptual Framework. Anesth Analg. 2019 Oct;129(4):1181-1184. doi: 10.1213/ANE.0000000000004048. No abstract available.
Rosenbloom BN, Rabbitts JA, Palermo TM. A developmental perspective on the impact of chronic pain in late adolescence and early adulthood: implications for assessment and intervention. Pain. 2017 Sep;158(9):1629-1632. doi: 10.1097/j.pain.0000000000000888. No abstract available.
Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.
Rabbitts JA, Palermo TM, Zhou C, Mangione-Smith R. Pain and Health-Related Quality of Life After Pediatric Inpatient Surgery. J Pain. 2015 Dec;16(12):1334-1341. doi: 10.1016/j.jpain.2015.09.005. Epub 2015 Sep 28.
Rabbitts JA, Zhou C, Narayanan A, Palermo TM. Longitudinal and Temporal Associations Between Daily Pain and Sleep Patterns After Major Pediatric Surgery. J Pain. 2017 Jun;18(6):656-663. doi: 10.1016/j.jpain.2017.01.004. Epub 2017 Jan 26.
Wang Z, Li Y, Lin D, Ma J. Effect of Melatonin on Postoperative Pain and Perioperative Opioid Use: A Meta-analysis and Trial Sequential Analysis. Pain Pract. 2021 Feb;21(2):190-203. doi: 10.1111/papr.12948. Epub 2020 Oct 2.
Other Identifiers
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IRB-71745
Identifier Type: -
Identifier Source: org_study_id
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