Evaluation the effects of different doses of Melatonin on pain control after surgery and their effects on the need for opioid and non-opioid analgesics in patients who are candidates for spinal anesthesia

Evaluation the effects of different doses of Melatonin on pain control after surgery and their effects on the need for opioid and non-opioid analgesics in patients who are candidates for spinal anesthesia: a double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230516058207N1

Enrollment

152

Registered

2023-06-13

Start date

2023-06-26

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

postoperative pain. Acute pain, not elsewhere classified

Interventions

Intervention 1: Intervention group: Group A received Melatonin sublingual tablet 3 mg (Norm Life manufactured by Amin Pharmaceutical Company, Iran)+ 1 sublingual placebo tablet (made in the growth cen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Be over 18 years old Candidate patients for spinal anesthesia Completing the informed consent form

Exclusion criteria

Exclusion criteria: Patients with liver failure (liver enzymes more than triple the normal limit) Patients with renal failure (GFR<60) pregnancy Patients with brain tumors. Patients who have a history of neurological and psychological diseases People who take warfarin Drug abuse History of sensitivity to melatonin The patient's unwillingness to participate in the study

Design outcomes

Primary

Measure	Time frame
Intensity of pain. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.;Dosage of opioid analgesic after surgery. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Calculate the amount of medicine used.;The dosage of non-opioid analgesic after surgery. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Calculate the amount of medicine used.	—

Measure

Time frame

Intensity of pain. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.;Dosage of opioid analgesic after surgery. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Calculate the amount of medicine used.;The dosage of non-opioid analgesic after surgery. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Calculate the amount of medicine used.

—

Secondary

Measure	Time frame
Side effects include drowsiness, fatigue, confusion, headache, irritability, nausea, vomiting and itching. Timepoint: 1, 2, 6, 12 and 24 hours after surgery. Method of measurement: Ask the patient.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactIman Abdolkhani

Ahvaz University of Medical Sciences

abdolkhani.I@ajums.ac.ir+98 61 3338 5098

Outcome results

None listed

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