1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [srihari.jutoor@gmail.com].
   


6. For how long will this data be available start date provided 15-04-2022 and end date provided 01-01-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - na

        Preoperative anxiety is seen in 50%-70% of the paediatric patients posted for surgery. Fear of parent separation, fear of strange hospital environment and painful procedures contribute to preoperative anxiety.¹Children with high preoperative anxiety have high incidence of postoperative pain, emergence delirium, delayed discharge and maladaptive and behavioural changes that can last for weeks in the postoperative period.²

        Various pharmacological and non-pharmacological methods are in practice with variable success rate. Drugs, such as midazolam and ketamine, have been tried for this  via oral, nasal and parenteral routes, but each one has its limitations.³

        Inhalation of nebulised drug is an easy alternative for preoperative sedation in children as it avoids needle puncture necessary for intravenous (IV) or intramuscular (IM) route. Dexmedetomidine, which is a selective alpha-2 agonist with central sedative and anxiolytic properties,⁴ has been tried for preoperative anxiolysis in children via nasal and inhalational routes.⁵ Previous study has suggested that nebulised dexmedetomidine can provide a clinically relevant, non-invasive alternative to the invasive IV or IM route of administration.⁶Those studies have used dexmedetomidine in the doses of 2 μg kg−1 and found that it was effective in achieving calm parental separation in approximately 60%-70% of children.^7,8Dexmedetomidine in a dose of 3 µg kg−1 via parenteral route has produced satisfactory procedural sedation without any haemodynamic adverse events.^9,10