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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin 5 mg | Experimental | Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. |
|
| Melatonin 10 mg | Experimental | Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. |
|
| Placebo | Placebo Comparator | Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 mg melatonin | Dietary Supplement | Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain will be assessed over a 24 hour period following surgery using a visual analogue scale | 24 hours |
| Anxiety | Anxiety will be assessed over a 24 hour following surgery using visual analogue scale | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Peng, MD | Contact | 416 603-5118 | philip.peng@uhn.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Philip Peng, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33319916 | Derived | Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 10 mg melatonin | Dietary Supplement | Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. |
|
| Placebo | Dietary Supplement | Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery. |
|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |