A Phase 3 interventional study of 2 mg Melatonin and 10mg Melatonin in Anxiety, sponsored by United States Naval Medical Center, San Diego. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by United States Naval Medical Center, San Diego · Phase 3, Interventional, and Supportive care
Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic low back pain. This interventional pain procedure often occurs in the fluoroscopy suite. During this procedure, a physician inserts the needles to deliver local anesthetics such as lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many patients experience anxiety before and during the lumbar medial branch block procedure and require intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation requires one-to-one nursing care, monitoring, and recovery. In order to minimize the costs and time requirements of intravenous sedation, a suitable oral medication which is readily available and non-controlled would be ideal. Several randomized double-blinded, controlled trials have investigated the anxiolytic effects of melatonin before a surgery; however no studies to date have studied the anxiolytic effects of melatonin before less invasive interventional pain procedures. This study is designed to evaluate the efficacy of melatonin for reducing anxiety in patients undergoing a lumbar medial branch block procedure.
The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction in patients before undergoing the procedure. The primary outcome is measured by visual numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information Scale. Based on the results of previous studies, the investigators hypothesize that melatonin may reduce anxiety in patients undergoing the procedure and be a suitable alternative to intravenous sedation in the pain clinic for patients undergoing lumbar medial branch blocks.
Chronic low back pain is a common disease in industrialized countries which affect patients' productivity and quality of life. Currently, the estimated yearly prevalence of chronic low back pain in United States is 5-20%. Lumbar medial branch blocks (LMBB) are commonly used as a diagnostic tool for facet mediated chronic low back pain. This interventional pain procedure often occurs in the fluoroscopy suite. During this procedure, a physician inserts the needles to deliver local anesthetics such as lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint.
Many patients experience anxiety before the LMBB procedure and require intravenous midazolam or fentanyl for sedation. In fact, in a retrospective review of over 8,000 interventional fluoroscopically guided pain procedures, the highest incidence of vasovagal episodes occurred with LMBB procedures. A nurse is required to administer these medications and monitor patient's vital signs. In addition, recovery from these medications can unduly prolong the patients visit and, in the case of fentanyl, can confound the diagnostic utility of the LMBB procedure by decreasing patient's pain.
In an effort to minimize the cost of administration, monitoring, time of recovery and maximize the diagnostic utility of LMBBs, a suitable alternative is required. Several randomized, double-blinded, controlled trials investigate the anxiolytic effect of melatonin before a surgery. Several other studies and review articles describe the use of melatonin for both sedation and anxiolysis in both adults and children. However, no studies to date describe the use of melatonin for anxiolysis or sedation for interventional pain medicine procedures.
Melatonin ((N-acetyl-5-methoxytryptamine) is an over-the-counter product which patients can take to reduce anxiety before a procedure; it is a hormone produced in the pineal gland and secreted into the blood and cerebrospinal fluid. Melatonin has several functions including the regulation of circadian rhythms and regulation of the reproductive axis and antioxidant activity. Exogenous melatonin has been used to treat insomnia and jet lag.
5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →United States Naval Medical Center, San Diego is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 2mg melatonin.
Drug: 2 mg Melatonin
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of 10mg melatonin.
Drug: 10mg Melatonin
To remain within the doses used for anxiolytic effects in past studies, we plan to study the effects of two different levels of melatonin versus placebo as premedication in patients undergoing a lumbar medial branch block (LMBB) procedure.
Other: Placebo
40 patients will randomly receive 2 mg melatonin
Also known as: N-acetyl-5-methoxytripatamin
40 patients will randomly receive 10 mg melatonin
Also known as: N-acetyl-5-methoxytripatamin
40 patients will randomly receive a placebo/sugar pill
Also known as: Sugar Pill
Change in anxiety level scores as assessed by the data collection sheet given to patients at all three time points (listed below)
Comparing melatonin and placebo to see if differing levels of melatonin helps prevent or alleviate anxiety in service members undergoing an interventional pain procedure. For patients participating in the LMBB, anxiety level scores will be compared among the three time-points. Primary analysis will compare the two treatment groups versus placebo. The goal of this study is to demonstrate whether melatonin has anxiolytic effects preoperatively.
Time frame: Anxiety levels will be assessed at check-in time (90 minutes before procedure), immediately before procedure, and 90 minutes post-operatively.
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Plan to share: No
The record gives a start of Jul 2016, a primary completion of May 2022 and a completion of May 2022. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
United States Naval Medical Center, San Diego