Recruiting

MelatoninPerioperative Melatonin in Lumbar Laminectomy

Sponsor:

University Health Network, Toronto

Code:

NCT01126294

Conditions

Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

5 mg melatonin

10 mg melatonin

Placebo

Study Details

Brief 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.

Conditions

Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.

Study ID

NCT01126294

Start date

Apr, 2010

Status verified date

Apr, 2010

Completion date

Sep, 2011

Anticipated

Primary completion date

Jul, 2011

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

age 18 to 65 years old
ASA status 1-3
having lumbar laminectomy 2 to 3 levels with or without fusion

Exclusion Criteria:

receiving emergent procedure
surgery for neoplastic spine lesion
allergy to melatonin or its non-medicinal ingredients
allergy or contraindication
BMI over 35 or or less than 20 kg/m2
pregnancy or breastfeeding
failure to provide informed consent

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Melatonin 5 mg

Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.

experimental: Melatonin 10 mg

Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.

placebo comparator: Placebo

Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

Interventions

5 mg melatonin

Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.

10 mg melatonin

Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.

Placebo

Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.

Primary outcome measure

Pain [ Time Frame: 24 hours ]
Anxiety [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Philip Peng, MD

416 603-5118 philip.peng@uhn.on.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Uma Victor, MBBS

416 603-5800 uma.victor@uhn.on.ca

Principal Investigator:

Philip Peng, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 19, 2010

Last verified

Apr, 2010

Keywords

lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2010-05-19.