Effect of topical ketorolac and tetracaine on the need for sedative and analgesic drugs in phacoemulsification

Comparison of the effect of adding topical ketorolac and tetracaine drops on the need for sedative and analgesic drugs during and after phacoemulsification cataract extraction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170716035104N4

Enrollment

Registered

2019-06-24

Start date

2017-03-21

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

Cataract. Age-related cataract

Interventions

Intervention 1: Intervention group 1: One drop of tetracaine 0.5% eyedrop will be administered every 10 minutes for 30 minutes before the start of the procedure. Intervention 2: Intervention group 2:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All candidates of cataract surgery with phacoemulsification under local anesthesia and sedation according to the American Society of Anesthesiologists (ASA) class I and II

Exclusion criteria

Exclusion criteria: Tetracaine allergy Ketorolac allergy History of drug, cigarette, alcohol or benzodiazepine addiction Pregnancy Need for intraoperative alternation of anesthetic technique Opting out of the study

Design outcomes

Primary

Measure	Time frame
Patient's post-operative pain. Timepoint: At 0, 10 and 20 minutes after the patient's admission to the recovery. Method of measurement: The Visual Analogue Scale (VAS).;Midazolam doze required for sedation. Timepoint: During the surgery. Method of measurement: Measured based on milligrams using scaled syringe.;Propofol doze required for sedation. Timepoint: During the surgery. Method of measurement: Measured based on milligrams using scaled syringe.;Nausea and vomiting in patient. Timepoint: During recovery admittion. Method of measurement: The Visual Analogue Scale (VAS).;Patient's sedation score during and after the surgery. Timepoint: During the surgery and after admitting to the recovery. Method of measurement: Visual Analogue Scale (VAS).	—

Measure

Time frame

Patient's post-operative pain. Timepoint: At 0, 10 and 20 minutes after the patient's admission to the recovery. Method of measurement: The Visual Analogue Scale (VAS).;Midazolam doze required for sedation. Timepoint: During the surgery. Method of measurement: Measured based on milligrams using scaled syringe.;Propofol doze required for sedation. Timepoint: During the surgery. Method of measurement: Measured based on milligrams using scaled syringe.;Nausea and vomiting in patient. Timepoint: During recovery admittion. Method of measurement: The Visual Analogue Scale (VAS).;Patient's sedation score during and after the surgery. Timepoint: During the surgery and after admitting to the recovery. Method of measurement: Visual Analogue Scale (VAS).

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Secondary

Measure	Time frame
Mean of blood pressure (mm Hg). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Clinical mercury manometer.;Heart rate (beats per minute). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Beat count by palpating distal radius pulse.;Peripheral capillary oxygen saturation (percentage). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Pulse oximetry.;Respiratory rate (breaths per minute). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Capnometry.;Hypoxia. Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Pulse oximetry.;Respiratory depression. Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Capnometry.;The satisfaction of the patient and the surgeon according to the Visual Analogue Scale. Timepoint: During the admission in the recovery. Method of measurement: The Visual Analogue Scale (VAS).	—

Measure

Time frame

Mean of blood pressure (mm Hg). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Clinical mercury manometer.;Heart rate (beats per minute). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Beat count by palpating distal radius pulse.;Peripheral capillary oxygen saturation (percentage). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Pulse oximetry.;Respiratory rate (breaths per minute). Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Capnometry.;Hypoxia. Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Pulse oximetry.;Respiratory depression. Timepoint: Prior to the operation, at the 5th, 10th, 15th and 20th minute of the surgery, at the 5th, 10th, 15th and 20th minute after the surgery. Method of measurement: Capnometry.;The satisfaction of the patient and the surgeon according to the Visual Analogue Scale. Timepoint: During the admission in the recovery. Method of measurement: The Visual Analogue Scale (VAS).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Pourkhosravi

Esfahan University of Medical Sciences

hamedpourkhosravi@gmail.com+98 31 3620 1337

Outcome results

None listed

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