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IRCT20151003024317N13 IRCT 2022-01-19 Iran University of Medical Sciences Effect of intranasal midazolam with topical lidocaine ointment on the success of blood draw and cerebrospinal fluid retrieval Comparison of the effect of intranasal midazolam with topical lidocaine ointment with intranasal midazolam alone on the success of blood draw and cerebrospinal fluid retrieval 2022-02-04 anticipated 80 Complete https://irct.ir/trial/61108 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups by using a random number table. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 8. In each block, 4 individuals will be in intervention group and 4 will be in control group. A total of 10 blocks will be considered for the study, Blinding description: Patients (child caregivers) will be unaware and blind to the type of treatment. To hide, similar ointments were used, without the drug name tag and only with the code. Child caregivers will be aware that they will be randomly assigned to one of the two treatment groups, but will not know which treatment will be offered in that group. Children will be placed in one of two groups using a table of random numbers. The clinician also knows that children will be treated in two different ways, but will not know which method will be used for each child. The data collector, analyst and outcome assessor will collect and analyze the information based on groups 1 and 2 and will not be aware of the type of treatment provided in the groups and will be kept blind. 3 Cerebrospinal fluid retrieval. Intervention 1: Intervention group: children will receive intranasal midazolam with lidocaine ointment topically in the process of blood sampling and cerebrospinal fluid collection, and each person will be given 5 to 10 micrograms per kilogram of nasal midazolam weight with lidocaine ointment. Intervention 2: Control group: Control group: Children receive intranasal midazolam alone during blood sampling and cerebrospinal fluid collection, and each person will be given 5 to 10 micrograms per kilogram of intranasal midazolam weight. 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 After completing the work and consulting with all the writers and executive agents, I will be decided.
public Shaqayeq Khosravi
Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 009886701 shaqayeq.khosravi@gmail.com Iran University of Medical Sciences scientific Shaqayeq Khosravi
Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 009886701 shaqayeq.khosravi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Children over 1 year Suffering from a variety of neurological and infectious diseases 1 year 7 years Both Children over 7 years Weight less than 10 kg Decreased level of consciousness Underlying neurological impairment Use of analgesics 12 hours before puncture Acute or chronic respiratory, renal, and hepatic disorders G97.0 Cerebrospinal fluid leak from spinal puncture Treatment - Drugs Treatment - Drugs Intervention group: children will receive intranasal midazolam with lidocaine ointment topically in the process of blood sampling and cerebrospinal fluid collection, and each person will be given 5 to 10 micrograms per kilogram of nasal midazolam weight with lidocaine ointment. Control group: Control group: Children receive intranasal midazolam alone during blood sampling and cerebrospinal fluid collection, and each person will be given 5 to 10 micrograms per kilogram of intranasal midazolam weight. Respiratory disorders. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record. The amount of pain. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record. Percentage of oxygen saturation. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record. Heart rate. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record. Respiratory rate. Timepoint: After blood sampling and cerebrospinal fluid collection, 3 hours, 6 hours and 12 hours after that. Method of measurement: Based on the information recorded in patient's record. Iran University of Medical Sciences Approved 2021-06-29 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)