The anxiolytic and analgesic effects of melatonin: a study protocol for a randomized, double-blind, placebo-controlled study

The anxiolytic and analgesic effects of melatonin

  • Bennedikte Kollerup Madsen Department of Surgery D, Herlev Hospital, University of Copenhagen, DK-2730 Herlev, Denmark
  • Dennis Zetner, MD Department of Surgery D, Herlev Hospital, University of Copenhagen, DK-2730 Herlev, Denmark
  • Lars Peter Kloster Andersen, MD Department of Anesthesia and Intensive Care Z, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, DK-2400 Copenhagen, Denmark
  • Jacob Rosenberg, DMSc Department of Surgery D, Herlev Hospital, University of Copenhagen, DK-2730 Herlev, Denmark
DOI: https://doi.org/10.32794/mr11250019
Keywords: Melatonin, Anxiety, Pain, Perioperative

Abstract

 

Anxiety and pain are both significant clinical challenges following surgery. Melatonin has been demonstrated to have both anxiolytic and analgesic effects in numerous experimental and clinical studies. This study protocol aims to present the design of a randomized study investigating the anxiolytic and analgesic effects of exogenous melatonin in cosmetic breast augmentation.

     The study will be a randomized, double-blind, placebo-controlled trial. Included patients are candidates for primary breast augmentation or replacement of existing implants. Patients receive a standardized general anesthetic and postoperative analgesic regimen. The study medication includes 4 separate doses, containing either 10 mg of melatonin or placebo. Doses are administered orally at 21:00 hours of the night before surgery, 120 minutes before surgery, immediately after surgery in the post-anesthesia care unit, and at 21:00 hours of the night following surgery.

     The two primary outcomes are preoperative anxiety, assessed by the State-Trait Anxiety Inventory and pain, measured by an integrated assessment of longitudinally measured pain intensity and opioid consumption. Secondary outcomes are VAS anxiety, and VAS pain, sleep quality, general fatigue and wellbeing.

     This study protocol presents in detail the design of a randomized, double-blind, placebo-controlled study investigating the anxiolytic and analgesic effects of repeated doses of exogenous melatonin in patients undergoing cosmetic breast augmentation.  

 

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Published
2019-06-08
How to Cite
[1]
Kollerup Madsen, B., Zetner, D., Andersen, L.P. and Rosenberg, J. 2019. The anxiolytic and analgesic effects of melatonin: a study protocol for a randomized, double-blind, placebo-controlled study. Melatonin Research. 2, 2 (Jun. 2019), 22-34. DOI:https://doi.org/https://doi.org/10.32794/mr11250019.
Issue
Vol 2 No 2 (2019): Melatonin research
Section
Research Articles
DOI
https://doi.org/10.32794/mr11250019
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