Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01505465|
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Delirium Confusion Sleep||Drug: Melatonin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Perioperative Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Experimental: Study: Melatonin||
5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
|Placebo Comparator: Control: Placebo||
5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
- Perioperative Sleep Efficiency [ Time Frame: 96 hours before surgery to 72 hours after surgery ]Sleep time change from 96 hours before surgery to 72 hours after surgery
- Perioperative Effects of Melatonin on Post-operative Pain Scores [ Time Frame: Up to postoperative day 3 ]A difference in 25% in average pain score at each time point be considered clinically significant.
- Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older [ Time Frame: Up to postoperative day 3 ]A difference of 25% will be considered clinically important.
- Melatonin Effects on Daytime Activity [ Time Frame: Up to postoperative day 3 ]A 20% difference will be considered clinically important.
- Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage [ Time Frame: Up to 3 days ]A 25% in narcotic usage will be considered clinically important
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505465
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Stavros G. Memtsoudis, MD, PhD||Hospital for Special Surgery, New York|