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

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

Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 80 patients. In order to randomize, the block randomization method will be used.

In this study, all children who go to Ali Asghar Hospital for blood sampling and cerebrospinal fluid collection will be included in the study. Children will be randomly divided into 2 groups based on size 8 blocks. The sample size for each study group will be 40 people. A total of 80 patients will be screened. They will be child caregivers and information analysts will be blind.

Inclusion criteria: children older than 1 years old; suffering from a variety of neurological and infectious diseases. Exclusion criteria: children over 7 years old; 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.

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: 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; The amount of pain; Percentage of oxygen saturation.

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.

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.