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IRCT20180205038631N1 IRCT 2019-09-29 Ahvaz University of Medical Sciences The effect of midazolam on headache The effect of midazolam on prevention of post dural puncture headache 2018-05-20 anticipated 120 Complete https://irct.ir/trial/41817 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method was used for randomization. Thirty blocks were created by www.randomizer.org. The blocks were the same size and equal to 4. In each block, there were two allocations for the intervention group and two allocations for the control one. In each block, 1 and 2 numbers were given in different order, which determined the group of patients. Number one was considered as intervention group and number two was used as control group. Patients were randomly assigned to intervention or control groups after being nominated for lumbar puncture on the basis of one and two numbers in blocks.Also the random sequence of blocks was in the hands of an individual other than the researcher who, by telephone, provided only the required number indicating the intervention or control group. Without researchers intervention, the patients were assigned to each groups based on numbers. After sampling accomplisehed, each groups had the same size with number of 60, Blinding description: None of the patients in this study knew that they were in the intervention or control group and that the treatment received was either drug or placebo. 3 Post dural puncture headache. Intervention 1: Intervention group: 3 milligram midazolam diluted in normal saline and volume of 5 milliliter was injected intravenously five minutes before dural puncture in single dose. Intervention 2: Control group: Only 5 milliliter normal saline was injected intravenously five minutes before dural puncture in single dose. 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 No more information.
public Davood Kashipazha
Department of Neurology, Golestan Hospital, Farvardin St., Golestan, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3012 dakashi47@gmail.com Ahvaz University of Medical Sciences scientific Davood Kashipazha
Department of Neurology, Golestan Hospital, Farvardin St., Golestan, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3012 dakashi47@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Undergoing diagnostic lumbar puncture for any indication 18 to 60 years old 18 years 60 years Both Any known chronic pulmonary disease Known sensitivity to benzodiazepines Decreased level of consciousness or other conditions that the patient is unable to tell us about his headache. Pregnancy G97.1 Other reaction to spinal and lumbar puncture Treatment - Drugs Placebo Intervention group: 3 milligram midazolam diluted in normal saline and volume of 5 milliliter was injected intravenously five minutes before dural puncture in single dose. Control group: Only 5 milliliter normal saline was injected intravenously five minutes before dural puncture in single dose. Incidence of post dural puncture headache. Timepoint: This evaluation was performed at 6, 12, 24, 48, 72 and on the fourth and fifth days after lumbar puncture. Method of measurement: Diagnostic criteria of the International Classification of Headache Disorders, third edition (beta version). The severity of post dural puncture headache. Timepoint: This evaluation was performed at 6, 12, 24, 48, 72 and on the fourth and fifth days after lumbar puncture. Method of measurement: Visual Analogue Scale. The duration of post dural puncture headache. Timepoint: This evaluation was performed at 6, 12, 24, 48, 72 and on the fourth and fifth days after lumbar puncture. Method of measurement: Daily headache diary. Ahvaz University of Medical Sciences Approved 2018-05-19 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Development Research and Technology, Ahwaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan Blvd, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)