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IRCT20211225053512N1 IRCT 2022-12-07 Shahid Beheshti University of Medical Sciences Comparison of the effectiveness of pharmacological and non-pharmacological methods of reducing pain in retinopathy of prematurity examination Comparison of the effectiveness of pharmacological and non-pharmacological methods of reducing pain in retinopathy of prematurity examination 2022-12-19 anticipated 300 Complete https://irct.ir/trial/63345 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: According to the definition of the World Health Organization, babies who are born before the 37th week from the first day of the last menstrual period are considered premature, Randomization description: Random sampling based on the table of random numbers (at least 100 babies in each group).Allocation of patients in two groups was done by random block allocation method. The allocation sequence was generated using the free web-based system https://www.sealedenvelope.com/. To produce the sequence, the number of subjects in each block is 6 and 4, and letters A are for the intervention group and letters B are considered for the control group. Finally, 200 samples (24 blocks of 6 and 14 blocks of 4) have been produced in two groups A and B, Blinding description: In this study, Double Blinde Randomized Control Trial (double blind clinical trial), We decided to put eligible infants in three groups of ketamine and fentanyl and non-pharmacological methods and compare their effectiveness in preventing pain. At least 100 babies in each group are included in the study based on the inclusion criteria and are randomly assigned to three treatment groups. Then, treatment groups are compared based on PIPP (premature infant pain index) which is measured by someone other than a nurse. 3 Pain reduction in the eye examination of premature babies.. Intervention 1: Intervention group 1: The non-pharmacological group of SADDLING babies - pacifiers and oral sucrose 25% half cc per kilogram of weight. Intervention 2: Intervention group 2: Ketamine 2mg/kg nasally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later. Intervention 3: Intervention group 3: Fentanyl 2 µg/kg nasally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later. Intervention 4: Intervention group 4: Acetaminophen 2 drops/kg orally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: The access period starts 6 months after the results are published. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: It will be available only for researchers working in academic and scientific institutions after the official approval of the supervisor and main supervisor, and other personal analyzes are not allowed. Where to obtain: Mrs. Dr. Maryam Khoshnood Shariati Mahdieh Hospital Tehran How to obtain: Visiting in person or calling Dr. Maryam Khoshnoud Shariati at Mahdieh Hospital in Tehran and registering a legal request at the Vice-Chancellor of Education at Mahdieh Hospital. Comments:
public Hamed Razi
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 mahdiyeh_hospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Maryam Khoshnoud Shariati
Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 mahdiyeh_hospital@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Be hemodynamically stable Be alert And be able to tolerate 25% oral sucrose At least one hour has passed since the feeding The examination will also be done before the next meal no limit 37 months Both The baby of an addicted mother Taking sedative before examination Connected to the ventilator Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: The non-pharmacological group of SADDLING babies - pacifiers and oral sucrose 25% half cc per kilogram of weight. Intervention group 2: Ketamine 2mg/kg nasally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later. Intervention group 3: Fentanyl 2 µg/kg nasally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later. Intervention group 4: Acetaminophen 2 drops/kg orally is given to the patient thirty minutes before each examination by the nurse. Before pouring the ketamine drugs, the noses are suctioned and cleaned by pouring a drop of normal saline, and the drops are poured 5 minutes later. Gestational age. Timepoint: After the examination, the vital signs are monitored for 24 hours. Method of measurement: Premature infant pain profile. Shahid Beheshti University of Medical Sciences Approved 2022-04-25 Vice President of Research and Technology Shahid Beheshti University of Medical Sciences. Mahdieh Hospital., Shahid Rajabnia Street., Shishagar Alley., Fadaiyan Islam Street., Shush Street., Tehran., Iran Tehran Tehran Iran (Islamic Republic of)