Does Melatonin Improve Sleep Following Primary Total Knee Arthroplasty? A Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
BACKGROUND
Sleep impairment following total knee arthroplasty (TKA) is common and may decrease patient satisfaction and recovery. Standardized postoperative recommendations for sleep disturbances have not been established. We aimed to assess whether melatonin use could promote healthy sleep and reduce sleep disturbance in the acute period following TKA.
METHODS
Patients undergoing primary, elective TKA between July 19, 2021 and January 4, 2024 were prospectively enrolled and randomized to receive either 5 mg of melatonin nightly or placebo for 14 days postoperatively. Participants recorded their nightly pain on the visual analog scale, the number of hours slept, and the number of nighttime awakenings in a sleep diary starting the night of surgery (postoperative day [POD] 0). Sleep disturbance was assessed preoperatively and on POD 14 using the patient-reported outcome measurement information system sleep disturbance form. Epworth Sleepiness Scores were collected on POD 14 to assess sleep quality.
RESULTS
Of the 138 patients enrolled, 128 patients successfully completed the study protocol, with 64 patients in each group. Melatonin patients trended towards more hours of sleep on POD 2 (placebo: 5.0 ± 2.4, melatonin: 5.8 ± 2.0, P = 0.084), POD 3 (placebo: 5.6 ± 2.2, melatonin: 6.3 ± 2.0, P = 0.075), and averaged over POD 1 to 3 (placebo: 4.9 ± 2.0, melatonin: 5.6 ± 1.8, P = 0.073), though no differences were observed on POD 4 or after. Fewer nighttime awakenings in the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 138 participants or records.
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