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
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Article Info
Publication History
Published online: October 13, 2022
Accepted:
October 11,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
