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Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery

NCT01505465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-11

Study results available
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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

Conditions

  • Postoperative Pain
  • Delirium
  • Confusion
  • Sleep

Interventions

DRUG

Melatonin

5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.

DRUG

Placebo

5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Stavros G. Memtsoudis, MD, PhD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505465 on ClinicalTrials.gov