Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
|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|
|Postoperative Pain Delirium Confusion Sleep||Drug: Melatonin Drug: Placebo|
|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|
|Primary Completion Date :||June 2013|
|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
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|