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IRCT20230117057153N1 IRCT 2023-02-01 Tehran University of Medical Sciences Comparison of the effect of midazolam in oral and nebulized form Assessment and Comparison of the effectiveness of nebulized vs. oral midazolam as a sedative premedication in pediatric eye surgery patients 2023-02-05 anticipated 70 Complete https://irct.ir/trial/68081 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A randomization list will be generated using a table with the random property in Excel. After that, the information will be sent in numbered sealed envelopes, Blinding description: The person assessing the outcomes of the information will be unaware of the drug given to each patients. 2-3 This study is conducted for sedation in children undergoing eye surgeries. The entry criteria of our children should not have any underlying disease and be between 3 and 7 years old.. Intervention 1: Intervention group: The patients will receive the nebulized midazolam will be 0.5 mg/kg in 5 cc normal saline and will be nebulized through the face mask. Intervention 2: Patients will recieve oral solution which is 0.5 mg/kg (the standard midazolam syrup) and the face mask used for them will not contain any form of drug. 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 explanation.
public Sumaiya Zahra
Dormitory Kuye Daneshgar, Amirabad, North Kargar St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1439957181 +98 21 8800 2651 sumaiyazahra110@gmail.com Tehran University of Medical Sciences scientific Sumaiya Zahra
Kuye Daneshgah, North Karegar, Amirabad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1439957181 +98 21 8889 6692 sumaiyazahra25998@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) ASA I and II Children aged 3 to 7 years Eye surgery under general anesthesia 3 years 7 years Both Patients with renal or hepatic dysfunction History of midazolam allergy History of asthma Pre-existing neurologic disease Other Other Intervention group: The patients will receive the nebulized midazolam will be 0.5 mg/kg in 5 cc normal saline and will be nebulized through the face mask. Patients will recieve oral solution which is 0.5 mg/kg (the standard midazolam syrup) and the face mask used for them will not contain any form of drug. Determining sedation level using RAMSAY score within 30 minutes after administration of nebulized vs oral midazolam in pediatric eye surgery patients. Timepoint: 30 minutes after drug administration. Method of measurement: RAMSAY sedation score (0-6). Time taken to reach RSS 4 (RSS= Ramsay Sedation Score ). Timepoint: Within 30 minutes whenever it reaches RSS 4. Method of measurement: Time Unit. Facemask acceptance during drug delivery. Timepoint: During the sedation procedure. Method of measurement: Four point Mask Acceptance Scale 1.Excellent: Unafraid, cooperative, and accepts mask easily. 2, Good: Slight fear of mask, easily reassurediii. 3. Fair: Moderate fear of mask, not calmed with reassuranceiv. 4. Poor: Terrified, crying and combative. Ease of separation from parents. Timepoint: At the end of drug delivery (after 30 minute). Method of measurement: Parental Separation Anxiety Scale (PSAS) Excellent = Patient unafraid, cooperative, or asleep Good= Slightly afraid/crying, quiet with reassurance Fair= Moderately afraid and crying, not quiet with reassurance Poor= Crying, need for restraint. Changes in oxygen saturation. Timepoint: Baseline (at 0 minute after nebulization), 15th miinute and at 30th minute. Method of measurement: Oxygen saturation by pulse oximetry. Changes in heart rate. Timepoint: At 0 minute after nebulization, 15th minute and 30th minute. Method of measurement: Heart rate in beat/minute. Changes in blood pressure. Timepoint: At 0 minute after nebulization, 15th minute and 30th minute. Method of measurement: Blood pressure in mmHg. Tehran University of Medical Sciences Approved 2023-01-12 Ethics comittee of Tehran University of Medical Sciences 13th Floor, Block- A, Central Headquarters of the Ministry of Health and Medical Education, Iran Sima Street, Quds Town (West), between South Flamek and Zarafshan, Quds Town (West), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)