Comparison of the efficacy of Intranasal Atomised Ketodex versus Intranasal Atomised Midazolam as a Premedicant for anxiolysis and sedation in children aged 1 to 10 years undergoing spinal dysraphism surgery- A randomized double-blinded controlled trial.

Preoperative anxiety can occur in as much as 80% of surgical patients.11 Two vulnerable groups of patients are females and children. While most female adults are usually concerned about the uncertainty of their future, their family, the success of the operation, and the safety of anaesthesia, the children, by contrast, will experience varying degrees of separation anxiety before an operation. Both psychological and pharmacological approaches are effective in decreasing preoperative anxiety. A child’s preoperative anxiety can pose a significant challenge for the anaesthetic team and can be distressing for parents. Evidence suggests that preoperative anxiety is associated with adverse outcomes, both clinical (increased requirements for analgesics and emergence delirium) and behavioural (sleep disturbances and enuresis)12Various drugs have been used as premedication to allay anxiety and facilitate the smooth separation of the child from parents such as midazolam, ketamine, dexmedetomidine, clonidine, melatonin and sufentanil.1 The ideal premedicant should be readily acceptable and should have a rapid onset of action, reliable effect and faster recovery from the sedative effect of the drug. Since there is a discrepancy in the results of various studies on the superiority of the atomised form of one drug given intranasally over another and there is no study comparing the effectiveness of intranasal atomised ketodex versus midazolam for premedication in children aged 1 to 10 years of age. Therefore, we would like to compare the effectiveness of intranasal atomised ketodex using dexmedetomidine at a dose of 1 μg/kg and ketamine at a dose of 3 mg/kg with intranasal atomised midazolam 0.4 mg/kg in children aged 1 to 10 years for premedication undergoing spinal dysraphism surgery and we hypothesize that intranasal atomized ketodex will be non-inferior to intranasal midazolam as a premedicant for anxiolysis and sedation in children aged 1-10 years undergoing spinal dysraphism surgery.