Comparison of the efficacy of oral and intranasal midazolam premedication on sedation before undergoing MRI in children

Comparison of the efficacy of oral and intranasal midazolam premedication on sedation before undergoing MRI in children

This study will be conducted as a randomized, controlled, double-blind (outcome evaluator and statistical analyzer), 3-arm phase 3 clinical trial with parallel groups, on 90 eligible patients. The table of random numbers provided by graphpad.com will be used for randomization.

This clinical trial will be conducted on eligible patients admitting to pediatric medical center, Tehran. Pre-sedation will be administered in the preparation room and anesthesia will be performed in the MRI room; Patients will randomly divided into one of 3 control , oral Midazolam and intranasal midazolam groups, and after receiving the intervention, the intended outcomes will be evaluated. In this study, the outcome evaluator and the statistical analyst are unaware of the type of groups.

Inclusion criteria: ASA class 1 to 2 according to the American Society of Anesthesiologists; Age is between 6 months to 6 years; The patient is a candidate for MRI under anesthesia; Exclusion criteria: The patient has upper gastrointestinal tract problems, or an active infection, or a structural disorders of the upper respiratory system, or patient is cyanotic, or Having a history of drug allergy, or Severe crying and restlessness of the child immediately before participation;.

Group 1: 0.5 mg/kg syrup Midazolam PO, 20 minutes prior parental separation to conducting anesthesia Group 2: 0.2 mg/kg nasal spray Midazolam intranasal, 20 minutes prior parental separation to conducting anesthesia Group 3 (Control group): routine anesthesia, without pre-sedation Routine anesthesia: induction with inhaled sevoflurane and 1ml/kg intravenous Propofol

Sedation scale

Randomization will be done by random number table method through blocks of 3 created by referring to www.sealedenvelope.com. In this method, 90 eligible patients will be randomly divided into 30 blocks including 3 patients; Then, each of the 3 patients in the block will be randomly assigned to one of the 3 study groups based on the sequence provided by the website, so that 30 patients will be assigned to each group.

In this study, the outcome assessor and the statistical analyst will be unaware of the type of intervention. A trained staff member (anesthetist) who is not a member of the research group, according to the randomization sequence, will enter the patients in the respective groups and prescribes the intervention.