]>
IRCT20130719014056N13 IRCT 2023-01-23 Arak University of Medical Sciences Comparison of anti-inflammatory eye drops in cataract surgery Comparison of sedation and analgesia of ketorolac and diclofenac eye drops with tetracaine in cataract surgery 2023-02-20 anticipated 99 Complete https://irct.ir/trial/67902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Postoperative pain. Intervention 1: Control group: 0.5% tetracaine eye drops along with artificial tear drops, one drop each every 10 minutes during 30 minutes before the operation. Intervention 2: First intervention group: 0.5% tetracaine eye drops along with 0.5% ketorolac drops, one drop each every 10 minutes during 30 minutes before the operation. Intervention 3: Second intervention group: 0.5% tetracaine eye drops along with 0.1% diclofenac drops, one drop each every 10 minutes during 30 minutes before the operation. 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
public Dr Hesameddin Modir
Alam El Hoda St., Shahid Shiroudi St.
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesameddin Modir
Alam El Hoda St., Shahid Shiroudi St.
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Cataract surgery candidate by Phaco method Obtaining informed consent for the intervention Age 35 to 85 years both sexes ASA class 1 and 2 35 years 85 years Both Lack of patient permission Presence of mental disorders History of chronic use of sedatives Alcohol and drug use Having an allergy to the drugs used R52.0 Acute pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: 0.5% tetracaine eye drops along with artificial tear drops, one drop each every 10 minutes during 30 minutes before the operation First intervention group: 0.5% tetracaine eye drops along with 0.5% ketorolac drops, one drop each every 10 minutes during 30 minutes before the operation Second intervention group: 0.5% tetracaine eye drops along with 0.1% diclofenac drops, one drop each every 10 minutes during 30 minutes before the operation Postoperative pain. Timepoint: Every 5 minutes during surgery and recovery and 1, 2 and 4 hours after surgery. Method of measurement: Visual analogue scale. Mean arterial pressure. Timepoint: Every 5 minutes until the end of the operation and during recovery. Method of measurement: non invasive blood pressure monitoring. Heart rate. Timepoint: Every 5 minutes until the end of the operation and during recovery. Method of measurement: Cardiac monitoring. The amount of sedation. Timepoint: Every 5 minutes during surgery and recovery and 1, 2 and 4 hours after surgery. Method of measurement: Ramsay scale. Arak University of Medical Sciences Approved 2022-12-11 Ethical Committee of Arak University of Medical Sciences Vice President of Research and Technology, University Complex of the Prophet (PBUH),Arak City, Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)