Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Total Joint Arthroplasty; Sleep Disturbance

Treatments: Drug: Placebo; Drug: melatonin 6mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04590742

JJP17D.511

Details and patient eligibility

About

The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Enrollment: 154 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients who undergo unilateral primary total joint arthroplasty
2. Patient willing and able to complete postoperative surveys

Exclusion criteria

1. Patients who undergo revision total joint arthroplasty
2. Patients who undergo bilateral total joint arthroplasty
3. Patients currently taking melatonin supplementation
4. Patient has history of substance abuse (drug or alcohol)
5. Patient is a workman's comp patient or patient has current litigation pending
6. Patient has an allergy to melatonin
7. Patient has a history of delirium/psychiatric/depression/on antidepressants
8. Patient has a history of insomnia/ on sleep aid medication
9. Anyone on warfarin
10. Sleep apnea
11. Patient discharged to SNF or rehab
12. Patients who have inflammatory conditions
13. Shift work or night work

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

Placebo Tablet

Treatment:

Drug: Placebo

Group 2

Active Comparator group

Description:

Melatonin (6mg)

Treatment:

Drug: melatonin 6mg