Comparison of sedation and analgesia of ketorolac and diclofenac eye drops with tetracaine in cataract surgery

Comparison of sedation and analgesia of ketorolac and diclofenac eye drops with tetracaine in cataract surgery

Parallel group clinical trial with a control group, double blinded, randomized, phase 3 on 99 patients. Sealed envelope software was used for randomization.

This study is a randomized and double blinded clinical trial in which patients who are candidates for cataract surgery will be included in the study at Amirkabir Hospital in Arak city.In this study, the patients and the data collector do not know about the grouping of the patients and are blinded.

Inclusion criteria: age 35 to 85 years old; both sexes;' ASA class 1 and 2; Cataract surgery candidate by Fico method; obtaining informed consent for the intervention; absence of mental disorders; absence of history of chronic use of sedatives; not using alcohol and drugs; not having an allergy to the drugs used. Exclusion criteria: lack of patient permission; the presence of any complications during the operation that lead to changing the anesthesia method used or canceling the surgery.

The first group: 0.5% tetracaine eye drops along with artificial tear drops, one drop each every 10 minutes during 30 minutes before the operation. The second group: 0.5% tetracaine eye drops along with 0.5% ketorolac drops, one drop each every 10 minutes during 30 minutes before the operation. The third group: 0.5% tetracaine eye drops along with 0.1% diclofenac drops, one drop each every 10 minutes during 30 minutes before the operation.

Ramsay scale to evaluate patient sedation and VAS Score to evaluate patient pain

Patients will be randomly divided into three groups by block method in the form of blocks of 3 or 6. Eligible patients will be assigned to three intervention groups in the order of entry and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 or 6 blocks will be used in such a way that by using the random number generation software, the randomization sequence will be generated according to the required sample size on three groups. All these works will be done with a software called Sealed Envelope. By using this method, concealment will be achieved . The concept of concealment is the unpredictability of assigning people to groups, which means that the researcher will not be able to predict which group the next person will be in. Therefore, patients will be divided into 3 equal groups using the block allocation method.

The eye drops used in groups are prepared and prescribed by an anesthesiologist who knows the type of drugs and groupings (the preparation of each drop is such that the container corresponding to each drop is covered with colored paper of a specific color so that the patients will not know the drop type used and the group in which they are placed ) Also, the person collecting information who is a collaborator of the project is completely unaware of which group the patient is in, and the corresponding surgeon is also blinded to the drugs and groups. Also, all surgeries will be performed by one person.