Knee cohort for Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Knee+2 More
Melatonin 5 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study the effects of melatonin on sleep quality, length of stay, and opioid consumption for patients undergoing hip or knee surgery.

Eligible Conditions
  • Knee

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Visit 1 (Screening Visit), Visit 2 (2 months post surgery)

Day 14
Change in narcotic consumption patterns
Change in quality of hospital length of stay
Month 2
Change in Sleep Disturbance
Change in the quality of sleep

Trial Safety

Trial Design

4 Treatment Groups

Knee cohort
1 of 4
Hip cohort
1 of 4
Knee cohort control
1 of 4
Hip cohort control
1 of 4

Active Control

Non-Treatment Group

252 Total Participants · 4 Treatment Groups

Primary Treatment: Knee cohort · Has Placebo Group · N/A

Knee cohort
Drug
ActiveComparator Group · 1 Intervention: Melatonin 5 mg · Intervention Types: Drug
Knee cohort control
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Hip cohort
Drug
ActiveComparator Group · 1 Intervention: Melatonin 5 mg · Intervention Types: Drug
Hip cohort control
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: visit 1 (screening visit), visit 2 (2 months post surgery)

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,251 Previous Clinical Trials
743,526 Total Patients Enrolled
Josh Rozell, MDPrincipal InvestigatorNYU Langone Health
Joshua C Rozell, MDPrincipal InvestigatorNYU Langone Health

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.