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Melatonin 5 mg for Pain and Anxiety in Patients Undergoing Lumbar Laminectomy
N/A
Waitlist Available
Led By Philip Peng, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
age 18 to 65 years old
ASA status 1-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Study Summary
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Pain
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Melatonin 5 mgExperimental Treatment1 Intervention
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Group II: Melatonin 10 mgExperimental Treatment1 Intervention
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
Group III: PlaceboPlacebo Group1 Intervention
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,715 Total Patients Enrolled
Philip Peng, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
40 Total Patients Enrolled
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