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IRCT20200915048724N1 IRCT 2020-10-29 Shiraz University of Medical Sciences The efficacy of oral pain relief cocktail during panretinal photocoagulation for diabetic retinopathy The efficacy of oral pain relief cocktail during panretinal photocoagulation for diabetic retinopathy: a randomized clinical trial 2020-10-22 anticipated 30 Complete https://irct.ir/trial/51345 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: Oral medications were given one hour before PRP. Pain sensation is assessed immediately after treatment by verbal rating scale, which is a useful clinical pain index for pain intensity in postoperative patients. The verbal scale included a range of 0 (painless in all), 1 (slight discomfort), 2 (mild pain), 3 (moderate pain), 4 (severe pain), up to 5 (very painful). Blood pressure and heart rate are recorded by a digital blood pressure monitor 15 minutes before and immediately after treatment. Before laser treatment, measurements are performed after rest for at least 15 minutes. The statistics of the variables described as standard mean and deviation are expressed. The retin of each patient entering the study is divided into four regions :(ST/SN/IT/IN) and one area of two eyes is lasered in each session. According to the random table, each patient will be given one of the four treatment plan before laser and the patient's pain will be recorded immediately, Randomization description: In this study, a simple randomization method using a table of random numbers has been used. 30 patients are included in this study. Depending on the time of enrollment, a number from 1 to 30 is assigned to each patient. Each patient needs four sessions of laser treatment. Also, for each patient, four pain relief interventions are considered, which are marked with the letters A, B, C, D. For each laser treatment session, based on the table of random numbers in the first row from left to right, the last two digits and the number 00-24 for intervention A and 25-49 for intervention B and 50-74 for intervention C and 75-99 for intervention D are considered. After determining the sequence of interventions for 30 patients, opaque envelopes were used for concealment. The order of interventions is placed on cards in the envelope and each envelope is assigned to one patient. During the treatment, a third person delivers the analgesic drug to the patient based on this sequence before the laser, Blinding description: The present study is an interventional double-blind randomized clinical trial in which a specialist and patient will not know the type of medication received at each stage.Each patient will be given numbers from 1 to 30 and each number will be entered in the randomization table and according to the table, one of the four treatment plan will be performed at each patient's visit. The nurse who delivers the drug to the patient according to the randomization table is aware of the type of medication.The data collector and those who assess the outcome are unaware of the type of drug used. 2-3 prolifrative Diabetic retinopathy-non prolifrative Diabetic retinopathy. Intervention 1: Intervention group: At first, 30 patients (60 eyes) are studied, each patient's retin is divided into four parts and in each session one area of each eye is lasered one hour before the laser according to the drug randomization table is given to the patient. This drug can be placebo, navafen,150mg capsule combination of navafen and150mg capsule pregabalin.The patient's pain sensation will be measured immediately after each PRP ward using the Visual AnalogUe Scale (VAS). In four sessions for laser one-quarter retin, he receives three sessions of analgesics and in one placebo session. Intervention 2: Control group: In this study, each patient receives three sessions of analgesics in four sessions for one-quarter retin laser and in one placebo session. Yes - There is a plan to make this available What will be shared: All potential data is shareable after people are identified When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions and people who are also engaged in the industry Conditions: No other terms for using data or documentation Where to obtain: mkjoharii@gmail.com Mohammad karim Johari How to obtain: Send request to introduced email Comments:
public Mohammad hossein norouzzade
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 mkjoharii@gmail.com Shiraz University of Medical Sciences scientific Mohammad karim Johari
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz,
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 mkjoharii@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) age: years old proliferative diabetic retinopathy severe non-proliferative diabetic retinopathy no previous laser treatment best corrected visual acuity of 20/200 or better intraocular pressure under 21 mmHg spherical equivalent of ± 5.00 diopters clear media and vitreous severe non-proliferative diabetic retinopathy 51 years 69 years Both previous photocoagulation treatment media opacity such as cataracts, corneal diseases or vitreous hemorrhage unilateral PDR chronic use of analgesics history of any side effects related to pregabalin or novafen Myopic more or equal to 6 Renal Failure E08.321 Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema Treatment - Surgery Placebo Intervention group: At first, 30 patients (60 eyes) are studied, each patient's retin is divided into four parts and in each session one area of each eye is lasered one hour before the laser according to the drug randomization table is given to the patient. This drug can be placebo, navafen,150mg capsule combination of navafen and150mg capsule pregabalin.The patient's pain sensation will be measured immediately after each PRP ward using the Visual AnalogUe Scale (VAS). In four sessions for laser one-quarter retin, he receives three sessions of analgesics and in one placebo session. Control group: In this study, each patient receives three sessions of analgesics in four sessions for one-quarter retin laser and in one placebo session. Pain in VAS Questionnaire. Timepoint: patient scored the pain sensation immediately after each PRP section using Scott& rsquo s visual analogue scale (VAS). Method of measurement: visual analogue scale (VAS). Blood pressure. Timepoint: Blood pressure were taken by a digital blood pressure monitor 15 min before and immediately after laser treatment. Method of measurement: digital blood pressure monitor. Shiraz University of Medical Sciences Approved 2020-09-21 ٍٍEthics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, shiraz Fars Iran (Islamic Republic of)