CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Melatonin +1 moredrug
Likely dose
Melatonin 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01505465
NCT01505465N/ACompleted

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

Hospital for Special Surgery, New York·interventional·Posted Jan 6, 2012·Updated May 11, 2022

In Brief

A clinical study evaluating Melatonin and Placebo for Postoperative Pain and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago

Interventions

Melatonindrug

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

Placebodrug

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