Effect of melatonin on opioids used in patients undergoing laparotomy

The effect of sublingual melatonin on the use of opioids used in patients undergoing laparotomy admitted to the ICU

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220807055631N1

Enrollment

Registered

2022-08-30

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Appendicitis. Unspecified appendicitis

Interventions

Intervention 1: Intervention group:Intervention group: Patients will receive 5 mg of sublingual melatonin tablets (the company...) at 9:00 p.m. every night upon entering the intensive care unit. Medic

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years Patients undergoing laparotomy surgery requiring hospitalization in the intensive care unit for more than 48 hours

Exclusion criteria

Exclusion criteria: Presence of liver failure (liver enzyme more than three times the normal limit) Renal failure (GFR<60) History of brain tumor History of sensitivity to melatonin

Design outcomes

Primary

Measure	Time frame
The need to receive opioids. Timepoint: daily during ICU stay. Method of measurement: The need for narcotics (and drug dosage) based on the severity of the patient's pain and the doctor's diagnosis.;The need to receive antibiotics. Timepoint: daily during ICU stay. Method of measurement: Prescribing antibiotics based on doctor's diagnosis.;Changes in the amount of pain. Timepoint: daily during ICU stay. Method of measurement: based on visual analog scale (VAS).;Possible side effects. Timepoint: During ICU stay. Method of measurement: Based on the patient's examination and symptoms.	—

Measure

Time frame

The need to receive opioids. Timepoint: daily during ICU stay. Method of measurement: The need for narcotics (and drug dosage) based on the severity of the patient's pain and the doctor's diagnosis.;The need to receive antibiotics. Timepoint: daily during ICU stay. Method of measurement: Prescribing antibiotics based on doctor's diagnosis.;Changes in the amount of pain. Timepoint: daily during ICU stay. Method of measurement: based on visual analog scale (VAS).;Possible side effects. Timepoint: During ICU stay. Method of measurement: Based on the patient's examination and symptoms.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Ayoubzadeh

Ahvaz University of Medical Sciences

neginayoubzadeh@hotmail.com+98 61 3001 3374

Outcome results

None listed

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