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

This study aimed to evaluate the effect of using topical ketorolac and tetracaine drops on the need for analgesics in phacoemulsification cataract extraction.

This clinical trial is randomized, without any control group, community-based, pragmatic, with parallel groups and double-blinded.

This study will be carried out at the Feyz Hospital in Isfahan. Before surgery, patients will be hydrated to prevent the possible reduction in blood pressure. A group of patients will receive tetracaine and another group will receive ketorolac, and both groups will be sedated similarly using intravenous fentanyl, midazolam, and propofol. If there is a need for improving sedation, midazolam will be administered, followed by propofol if necessary. If blood pressure is low, ephedrine and atropine will be used after the administration of intravenous fluids. Monitoring will be continued before, during and after the surgery and the degree of sedation, severity of pain and nausea will be assessed according to the visual analogue scale (VAS).

All candidates for phacoemulsification cataract extraction undergoing local anesthesia and sedation based on ASA class I and II will be included in this study. The allergy to tetracaine or ketorolac, a history of drug addiction, smoking, alcohol and benzodiazepine abuse, pregnancy, need to change anesthetic technique during surgery or withdrawal from the study is considered as an exclusion criterion.

Tetracaine 0.5% eyedrop will be administered in the first intervention group, and ketorolac 0.5% eyedrop will be administered in the second intervention group. In both groups, every 10 minutes for 30 minutes before the start of the procedure, one drop will be prescribed.

Need for midazolam or propofol based on milligrams, the intensity of pain based on VAS scale

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.

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.