Comparing the effectiveness of preoperative injection of Melatonin-Fentanyl and Midazolam-Fentanyl on the amount of anxiety and pain in Cataract surgery under local anesthesia

Comparing the effects of Melatonin-Fentanyl and Midazolam-Fentanyl on pain and anxiety in Cataract

Clinical trial without a control group, with parallel groups, triple-blind, randomized with Random allocation software, phase 2 on 36 patients.

This is a triple-blind randomized clinical trial that will be performed on 36 Cataract candidate patients at Feyz Hospital in Isfahan. After the approval of the university ethics committee, if they have inclusion criteria, patients (or their guardians) will be informed about the study and if they consent, they will enter the groups with random assignment. In each group, the desired intervention is applied and the patient's clinical symptoms are recorded. The clinical caregiver evaluating the symptoms is different from the person performing the intervention and does not know the type of intervention. Patients, despite being studied, are not aware of the type of intervention applied and therefore are all blind. Data analysts also do not know the type of intervention applied in each group and are blind.

Inclusion criteria: over 18 years old, candidate for cataract surgery under local anesthesia, and informed consent to enter the study. Non-inclusion criteria: suffering from mental illness, deafness, diabetes, allergies, and obesity

Intervention group A: In this group, before surgery, patients receive a sublingual tablet containing 3 mg of Melatonin and 50 micrograms of Fentanyl injection, and 3 to 5 drops of topical Tetracaine 0.5% are poured on the eyeball in 4 directions.Intervention group B: In this group, patients receive 1 mg of Midazolam and 50 micrograms of Fentanyl injection before surgery, and 3 to 5 drops of 0.5% topical Tetracaine are poured on the eyeball in 4 directions.

The amount of sedation; The amount of pain

Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number.

This is a triple-blind clinical trial; In this way, before obtaining consent, patients are informed about the study but do not know which group they will be in and therefore are blind. Also, the researcher who records the patient's symptoms is different from the nurse who injects the drug and does not know the type of drug and is blind. Analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind.