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Completed

NCT Number: NCT01923974

The Analgesic Effects of Melatonin

A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.

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Key information

Conditions

Analgesia Agnosia Antihyperalgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males aged between 20 and 40 years

Exclusion criteria

  • Under aged/minors
  • Does not speak or understand danish
  • Alcohol or abuse of medicines
  • Prior QST-trial within the last 2 month
  • Prior medical trail within the last month
  • Serious comorbidity (ASA-class 3-4)
  • Chronic pain (defined by analgesic treatment) Shift-work or night work within the last 14 days Known sleep-disorder

Treatment and study plan

Melatonin 10 MG

Drug

Melatonin 100 mg

Drug

Placebo

Drug

Primary outcomes

  1. Pain (VAS)

    Time frame: During burn injury. 1 hours following melatonin/placebo administration

  2. Change in areas of secondary hyperalgesia

    Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration

    Areas of secondary hyperalgesia will be assessed by quantitative sensory testing

Secondary outcomes

  1. Change in erythema/oedema assessed by ultrasound

    Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration

  2. Thermal thresholds assessed by quantitative sensory testing

    Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration

  3. Mechanical thresholds assessed quantitative sensory testing

    Time frame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration

Sponsors and collaborators

Lead sponsor

Lars Peter Holst Andersen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 16, 2013
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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