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IRCT20170716035104N4 IRCT 2019-06-24 Esfahan University of Medical Sciences 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 2017-03-21 anticipated 86 Complete https://irct.ir/trial/39263 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by the "simple random sampling" method by "Random allocation" software. This software will randomly place the patients in the intervention and control groups based on its randomization algorithm, Blinding description: Participants will not be informed about the group they are assigned to (intervention or control). Also, the clinicians and the researchers will not have any information about the patients' groups (intervention or control) and medications used for them. 3 Cataract. 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: One drop of ketorolac 0.5% eyedrop will be administered every 10 minutes for 30 minutes before the start of the procedure. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information available
public Hamed Pourkhosravi
Isfahan University of Medical Sciences, Hezar Jarib Ave.
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3620 1337 hamedpourkhosravi@gmail.com Esfahan University of Medical Sciences scientific Dariush Moradi Farasni
Isfahan University of Medical Sciences, Hezar Jarib Ave.
Isfahan Iran (Islamic Republic of) ۷۳۴۶۱۸۱۷۴۶ +98 31 3620 1992 dmoradi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All candidates of cataract surgery with phacoemulsification under local anesthesia and sedation according to the American Society of Anesthesiologists (ASA) class I and II no limit no limit Both 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 H25 Age-related cataract Treatment - Drugs Treatment - Drugs 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 group 2: One drop of ketorolac 0.5% eyedrop will be administered every 10 minutes for 30 minutes before the start of the procedure 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). 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). Esfahan University of Medical Sciences Approved 2018-01-09 Ethics committee of Isfahan university of medical sciences Isfahan University Of Medical Sciences, Hezarjerib Ave., Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)