Comparison of melatonin and acetaminophen in cataract surgery

Comparison of melatonin and acetaminophen on pain and hemodynamic alterations associated with retrobulbar eye block in cataract surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015012315963N4

Enrollment

180

Registered

2015-03-11

Start date

2015-04-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

cataract. Senile cataract, unspecified

Interventions

Intervention 1: Placebo group will take placebo pill with water orally 60 min before arrival in the operating room. Intervention 2: Melatonin group will take 6 mg melatonin pill with water orally 60 m

Placebo

Treatment - Drugs

Placebo group will take placebo pill with water orally 60 min before arrival in the operating room

Melatonin group will take 6 mg melatonin pill with water orally 60 min before arrival in the operating room

Acetaminophen group will take 500 mg acetaminophen pill with water orally 60 min before arrival in the operating room

Eligibility

Sex/Gender

All

Age

50 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Patients aged 50-90 years with( ASA-PS)I- III ,scheduled for elective cataract surgery Exclusion criteria:coagulopathy; ongoing treatment with anti coagulant drugs ;Cognition disorders; Alzheimer's disease ;allergy to local anesthetic drugs ;Claustrophia ;chronic cough ; narcotics and opioids addiction; sedative drug users ; surgeries under general anesthsia ;surgical duration more than one hour and failure of retrobulbar block

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: visual analog scale.;O2 saturation. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: pulse oxymetery.;Heart rate. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: vital signs monitoring device.;Mean arterial pressure. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: vital signs monitoring device.	—

Measure

Time frame

Pain. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: visual analog scale.;O2 saturation. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: pulse oxymetery.;Heart rate. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: vital signs monitoring device.;Mean arterial pressure. Timepoint: before and 1 min after block ,5 min after and end of operation ,and in the recovery room. Method of measurement: vital signs monitoring device.

—

Secondary

Measure	Time frame
Nausia,vomitting. Timepoint: during retrobulbar block ,surgery and recovery. Method of measurement: Obsevation.;Low oxygen saturation level. Timepoint: during retrobulbar block ,surgery and recovery. Method of measurement: vital signs monitoring device.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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