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Evaluation the effect of melatonin on tourniquet pain

The effect of melatonin on sedation and tourniquet pain tolerance in intravenous regional anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160430027677N9
Enrollment
50
Registered
2018-12-31
Start date
2017-04-21
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Pain. Pain in arm, unspecified

Interventions

Intervention 1: Intervention group will be received Melatonin LLC USA Melatonin, Nature Made/Pharmative 6 mg tablet oral placebo 90 minutes before surgery. Intervention 2: Control group will be rec

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients aged 20-60 years Patients with American Society of Anesthesiologists (ASA) physical status classification I–II Elective upper limb surgery Surgery with intravenous regional anesthesia

Exclusion criteria

Exclusion criteria: Raynaud’s disease Sickle cell anemia Chronic pain syndromes Depression or schizophrenia Epilepsy Leukemia Autoimmune disease Diabetes Those who used any analgesic or sedative 24h before surgery Those with allergy to any of the study medications Pregnants Breast-feeding women

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Immediately after filling the tourniquet and in minutes 10, 20, 30, 40 and 50 during the surgery. Method of measurement: Verbal Pain Score.;Anxiety. Timepoint: Immediately after filling the tourniquet and in minutes 10, 20, 30, 40 and 50 during the surgery. Method of measurement: Verbal Anxiety Score.

Secondary

MeasureTime frame
Mean arterial pressure. Timepoint: Immediately after filling the tourniquet and in minutes 10, 20, 30, 40 and 50 during the surgery. Method of measurement: None invasive barometer pressure.;Heart rate. Timepoint: Immediately after filling the tourniquet and in minutes 10, 20, 30, 40 and 50 during the surgery. Method of measurement: Electrocardiogram.;Arterial oxygen saturation. Timepoint: Immediately after filling the tourniquet and in minutes 10, 20, 30, 40 and 50 during the surgery. Method of measurement: Pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahryar Sane

Oroumia University of Medical Sciences

sanesh@umsu.ac.ir+98 44 3223 4897

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026