The melatonin analgesic effect in a human pain model

The melatonin analgesic effect in a human nociceptive and inflammatory pain model.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-7m3mnd

Enrollment

Unknown

Registered

2012-03-31

Start date

2011-05-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pain

Interventions

In this study we'll have 4 groups of healthy volunteers (15 per group) that will be submitted to the intervention after basal pain tests (warm and heat pain threshold, heat pain tolerance and pressure

drug

D03.438.473.914.481

F02.463.593.710.560

G07.690.220

Eligibility

Age

No minimum to 45 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; Age between 18 and 45 years;

Exclusion criteria

Exclusion criteria: Current acute or chronic pain conditions; Pregnancy; Use of analgesics within 1 week; Use of any psychoative medications; Any chronic cardiac, rheumatologic, pulmonary, infectious or neurologic disease.

Design outcomes

Primary

Measure	Time frame
Increase in heat pain thresholds in a human pain model in healthy volunteers, using quantitative sensorial test. It is expected a decrease in pain in melatonin groups in a dose dependent way.;Increase in thermal pain tolerance in human pain model in volunteers using the quantitative sensorial test. It is expected a decrease in pain in melatonin groups in a dose dependent way.;Increase in pressure pain threshold in healthy volunteers measured by pressure algometer. It is expected that melatonin use will reduce pain in a dose-dependent way.;Increase in pressure pain threshold in healthy volunteers measured by pressure algometer. IIt is expected a decrease in pain in melatonin groups in a dose dependent way.	—

Measure

Time frame

Increase in heat pain thresholds in a human pain model in healthy volunteers, using quantitative sensorial test. It is expected a decrease in pain in melatonin groups in a dose dependent way.;Increase in thermal pain tolerance in human pain model in volunteers using the quantitative sensorial test. It is expected a decrease in pain in melatonin groups in a dose dependent way.;Increase in pressure pain threshold in healthy volunteers measured by pressure algometer. It is expected that melatonin use will reduce pain in a dose-dependent way.;Increase in pressure pain threshold in healthy volunteers measured by pressure algometer. IIt is expected a decrease in pain in melatonin groups in a dose dependent way.

—

Secondary

Measure	Time frame
Increase sedation levels measured by visual analogue scale. It is expected that the melatonin use increase the sedation levels in a dose-dependent way.	—

Countries

Brazil

Contacts

Public ContactLuciana Stefani

Hospital de Clínicas de Porto Alegre

lustefani@terra.com.br51-32643009

Outcome results

None listed

Source: REBEC (via WHO ICTRP)