Abstract
Objectives
Explore sleep disturbance in postoperative orthopedic trauma patients and determine
the impact of melatonin supplementation on postoperative sleep, pain, and quality
of life.
Materials and Methods
In this prospective, randomized controlled trial at a Level I trauma center, 84 adult
orthopedic trauma patients with operative fracture management were randomized 2-weeks
postoperatively to either the melatonin or placebo group. Patients randomized to the
melatonin group (42 subjects, mean age 41.8 ± 15.5 years) received 5 mg melatonin
supplements. Patients in the placebo group (42 subjects, mean age 41.3 ± 14.0 years)
received identical glucose tablets. Both groups were instructed to take the tablets
30 minutes before bed for 4 weeks and received sleep hygiene education and access
to the Cognitive Behavioral Therapy for Insomnia (CBT-I) Coach app.
Main Outcome Measures
Our primary outcome was sleep quality as measured by the Pittsburgh Sleep Quality
Index (PSQI). Secondary outcomes were pain measured by the Visual Analog Scale (VAS),
quality of life measured by the 36-Item Short Form Survey (SF-36), and opioid use.
Results
Patients in both groups had significant sleep disturbance (PSQI ≥ 5) at 2-weeks (83%)
and 6-weeks (67%) postoperatively. PSQI improved by 3.3 points (p<0.001) at follow-up,
but there was no significant difference between groups (melatonin PSQI = 5.6, placebo
PSQI = 6.1, P = 0.615). Compared to placebo, melatonin did not affect VAS, SF-36,
or opioid use significantly.
Conclusion
Sleep disturbance is prevalent in orthopedic trauma patients. Melatonin treatment
did not significantly improve subjective sleep quality, pain, quality of life or opioid
use.
Level of evidence
Therapeutic Level I.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to InjuryAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Sleep Disturbance in Orthopaedic Trauma Patients.J Orthop Trauma. 2018; 32: 500-504https://doi.org/10.1097/BOT.0000000000001276
- Trauma Sequelae are Uniquely Associated with Components of Self-Reported Sleep Dysfunction in OEF/OIF/OND Veterans.Behavioral Sleep Medicine. 2018; 16: 38-63https://doi.org/10.1080/15402002.2016.1173550
- Factors Related to Acute Anxiety and Depression in Inpatients with Accidental Orthopedic Injuries.Shanghai Arch Psychiatry. 2017; 29: 77-84
- Association of DSM-IV posttraumatic stress disorder with traumatic experience type and history in the world health organization world mental health surveys.JAMA Psychiatry. 2017; : 270-281
- Sleep disturbance as the hallmark of posttraumatic stress disorder.Am J Psychiatry. 1989; 146: 697-707https://doi.org/10.1176/ajp.146.6.697
- Factors influencing outcome after orthopedic trauma.J Trauma. 2008; 64: 1001-1009https://doi.org/10.1097/TA.0b013e31809fec16
- Factors Associated With Health-Related Quality of Life in Patients With Open Fractures.J Orthop Trauma. 2018; 32: e5-e11https://doi.org/10.1097/BOT.0000000000000993
- Sleep disturbances in orthopaedic trauma patients.OTA Int. 2019; 2: e040https://doi.org/10.1097/OI9.0000000000000040
- Self-reported sleep duration and coronary heart disease mortality: A large cohort study of 400,000 Taiwanese adults.Int J Cardiol. 2016; 207: 246-251https://doi.org/10.1016/j.ijcard.2016.01.044
- Association of sleep time with diabetes mellitus and impaired glucose tolerance.Arch Intern Med. 2005; 165: 863-867https://doi.org/10.1001/archinte.165.8.863
- Poor sleep quality is independently associated with physical disability in older adults.J Clin Sleep Med. 2015; 11: 225-232https://doi.org/10.5664/jcsm.4532
- Melatonin secretion after surgery.Lancet. 2000; 356: 1244-1245https://doi.org/10.1016/S0140-6736(00)02795-1
- Melatonin as a chronobiotic.Sleep Med Rev. 2005; 9: 25-39https://doi.org/10.1016/j.smrv.2004.05.002
- A novel approach to the prevention of postoperative delirium in the elderly after gastrointestinal surgery.Surg Today. 2002; 32: 310-314https://doi.org/10.1007/s005950200044
- The effects of melatonin prophylaxis on sensory recovery and postoperative pain following orthognathic surgery: a triple-blind randomized controlled trial and biochemical analysis.Int J Oral Maxillofac Surg. 2020; 49: 446-453https://doi.org/10.1016/j.ijom.2019.07.006
- Effect of Melatonin on Delirium After on-Pump Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial.Iran J Med Sci. 2021; 46: 120-127https://doi.org/10.30476/ijms.2020.82860.1146
- Effect of Melatonin on Sleep in the Perioperative Period after Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.J Clin Sleep Med. 2016; 12: 225-233https://doi.org/10.5664/jcsm.5490
- Efficacy of melatonin on sleep quality after laparoscopic cholecystectomy.Indian J Pharmacol. 2018; 50: 236-241https://doi.org/10.4103/ijp.IJP_250_18
- Impact of Melatonin on Sleep and Pain After Total Knee Arthroplasty Under Regional Anesthesia With Sedation: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.J Arthroplasty. 2015; 30: 2370-2375https://doi.org/10.1016/j.arth.2015.06.034
- Melatonin Does Not Improve Sleep Quality in a Randomized Placebo-controlled Trial After Primary Total Joint Arthroplasty.J Am Acad Orthop Surg. 2022; 30: e287-e294https://doi.org/10.5435/JAAOS-D-21-00243
- Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.Sleep Med. 2020; 76: 113-119https://doi.org/10.1016/j.sleep.2020.10.018
- A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy.Behav Ther. 2022; 53: 440-457https://doi.org/10.1016/j.beth.2021.11.003
- The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research.Psychiatry Res. 1989; 28: 193-213https://doi.org/10.1016/0165-1781(89)90047-4
- Acupuncture and Reflexology for Insomnia: A Feasibility Study.Acupunct Med. 2009; 27: 163-168https://doi.org/10.1136/aim.2009.000760
- Improvement in sleep quality after total shoulder arthroplasty.The Physician and Sportsmedicine. 2020; 48: 194-198https://doi.org/10.1080/00913847.2019.1671142
- Pulmonary rehabilitation and sleep quality: a before and after controlled study of patients with chronic obstructive pulmonary disease.npj Prim Care Resp Med. 2014; 24: 1-5https://doi.org/10.1038/npjpcrm.2014.28
- Physiotherapy for Sleep Disturbance in People With Chronic Low Back Pain: Results of a Feasibility Randomized Controlled Trial.Archives of Physical Medicine and Rehabilitation. 2013; 94: 2083-2092https://doi.org/10.1016/j.apmr.2013.04.017
- Minimal Clinically Important Difference and Patient Acceptable Symptom State for the Pittsburgh Sleep Quality Index in Patients Who Underwent Rotator Cuff Tear Repair.International Journal of Environmental Research and Public Health. 2021; 18: 8666https://doi.org/10.3390/ijerph18168666
- Alterations in the circadian rhythm of salivary melatonin begin during middle-age.Journal of Pineal Research. 2003; 34: 11-16https://doi.org/10.1034/j.1600-079X.2003.01897.x
- Sleeping characteristics of adults undergoing outpatient elective surgery: a cohort study.J Clin Anesth. 2003; 15: 505-509https://doi.org/10.1016/j.jclinane.2003.02.002
- Evaluation of sleep disorder in orthopedic trauma patients: a retrospective analysis of 1129 cases.J Orthop Surg Res. 2021; 16: 344https://doi.org/10.1186/s13018-021-02487-2
- Evaluating the Success of Perioperative Self-Guided Meditation in Reducing Sleep Disturbance After Total Knee Arthroplasty.J Arthroplasty. 2021; 36 (S215-S220.e2)https://doi.org/10.1016/j.arth.2021.01.070
- Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety.BMC Med. 2010; 8: 51https://doi.org/10.1186/1741-7015-8-51
- Sleep disorders and melatonin rhythms in elderly people.BMJ. 1994; 309: 167https://doi.org/10.1136/bmj.309.6948.167
- Nocturnal plasma melatonin levels in patients suffering from chronic primary insomnia.J Pineal Res. 1995; 19: 116-122https://doi.org/10.1111/j.1600-079x.1995.tb00179.x
- Melatonin treatment for age-related insomnia.J Clin Endocrinol Metab. 2001; 86: 4727-4730https://doi.org/10.1210/jcem.86.10.7901
- Effect of sustained nocturnal transbuccal melatonin administration on sleep and temperature in elderly insomniacs.J Biol Rhythms. 1998; 13: 532-538https://doi.org/10.1177/074873098129000354
- The effect of prolonged-release melatonin on sleep measures and psychomotor performance in elderly patients with insomnia.Int Clin Psychopharmacol. 2009; 24: 239-249https://doi.org/10.1097/YIC.0b013e32832e9b08
- Treatment of primary insomnia with melatonin: a double-blind, placebo-controlled, crossover study.J Psychiatry Neurosci. 2003; 28: 191-196
- Patient-Reported Outcome Measures (PROMs): Influence of Motor Tasks and Psychosocial Factors on FAAM Scores in Foot and Ankle Trauma Patients.J Foot Ankle Surg. 2020; 59: 758-762https://doi.org/10.1053/j.jfas.2020.01.008
Article info
Publication history
Published online: October 13, 2022
Accepted:
October 11,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.