1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


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 (Others) -  Clinical study will be available as original article as publication in a journal


6. For how long will this data be available start date provided 01-10-2027 and end date provided 01-10-2032?
   Response - Beginning 3 months and ending 5 years following article publication.
   


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

Surgery is a major life experience in a patient’s life, especially in children, as they undergo a stressful pre-operative period mainly due to parental separation. Unfamiliar faces, fear of doctors and needle injection may aggravate their anxiety leading to increased stress response, increased post-operative pain and increased need for analgesia. Thus, pre-operative sedation is necessary for children to allay the fear and decrease the separation anxiety of children from parents and aid in smooth induction.

Several drugs like midazolam, dexmedetomidine, ketamine, fentanyl and chlorhydrate have been used as premedication in children to ease parental separation and relieve anxiety. Midazolam is the most commonly used pre operative sedative. It is a short acting benzodiazepine with anxiolytic, amnestic, hypnotic, anticonvulsant and muscle relaxant actions. Fentanyl is a synthetic opioid with analgesic and sedative property. It has a rapid onset and short duration of action.

Pre medications are most commonly administered via the oral route, intranasal route, intramuscular route and rectal route. Intranasal administration is associated with high bioavailability of the drug and produces effective sedation with least patient discomfort.

Limited studies are available for comparing effects of nebulized fentanyl and midazolam as premedication in children. Hence, the present study has been designed to compare the effects of these drugs as sedative premedication in children undergoing surgery under general anesthesia.

In this research study we hypothesize that fentanyl when compared to midazolam will provide similar onset of sedation but better anxiolysis and shorter duration of action.

This study is a randomized controlled trial with a sample size of 72 and will be conducted in MS Ramaiah Medical College , Bangalore. The primary outcome will be to compare the time of onset of sedation between Fentanyl Group and Midazolam Group. The secondary outcome will be to compare Fentanyl(Group F) and Midazolam (Group M) with respect to

·         parental anxiety separation at 30 minutes

·         maximum level of sedation at the end of 30 minutes

·         mask acceptance scale scores

·         hemodynamic parameters