N/A
Completed N=50
Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
Postoperative Pain · Delirium · Confusion · Sleep
Source: ClinicalTrials.gov NCT01505465 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Perioperative Sleep Efficiency — 20; -55 minutes
Summary
Pain, confusion, and breaks in normal sleep cycles have been challenges commonly faced by patients after undergoing joint surgeries. To address these issues, melatonin, an inexpensive over-the-counter supplement, has shown in previous to help manage sleep disorders, prevent and treat post-operative confusion in patients over 70 years of age, and reduce pain. The purpose of this study is to establish whether melatonin can aid in reducing pain and post-operative confusion and improve sleep quality after total knee replacement
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Sleep Efficiency |
20; -55 | — |
| SECONDARY Perioperative Effects of Melatonin on Post-operative Pain Scores |
— | — |
| SECONDARY Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older |
— | — |
| SECONDARY Melatonin Effects on Daytime Activity |
— | — |
| SECONDARY Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients 18-90 years old undergoing elective, primary total knee replacement
- American Society of Anesthesiologists (ASA) Physical Status I-III
- Epidural anesthesia/Patient Controlled Analgesia candidate
Exclusion Criteria
- Mental impairment
- Pre-operative use of benzodiazepines, narcotics, or prescription/over-the counter (OTC) sleep aids
- Pre-operative use of calcium channel blockers
- Insomnia
- Recent drug or alcohol abuse
- Psychiatric disorders other than anxiety, including depression
- Diabetes
Data sourced from ClinicalTrials.gov (NCT01505465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.