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 -  Study Protocol
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [Katariasurbhii43@gmail.com].
   


6. For how long will this data be available start date provided 30-05-2028 and end date provided 12-10-2031?
   Response - Beginning 9 months and ending 36 months following article publication.
   


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

This randomised, double-blind, controlled study will be conducted to compare the analgesic efficacy of nebulisation with Dexmedetomidine and Lignocaine on postoperative pain in pediatric patient posted for tonsillectomy under general anaesthesia. The primary objective will be to compare the duration of postoperative analgesia while secondary objective will be to  compare the incidence and severity of emergence delirium, and compare the haemodynamic parameters preoperatively, intraoperatively and postoperatively between the groups , to assess and compare the sedation level using standardized sedation scale , to assess the level of anxiety by child separation score, to assess the incidence of adverse effects such as bradycardia, hypotension, respiratory depression ,nausea ,vomiting .The study will be carried out in Department of Anaesthesia OT complex & ENT ward at Bhagat Phool Singh Government Medical College , Khanpur Kalyan ,Sonepat , over a 18 month period, enrolling a total of 74 children aged 4 to 14 years undergoing tonsillectomy under general anaesthesia. Patients who meet the inclusion criteria (ASA physical status I or II) will be randomly allocated into two groups of 37 each. Group D (Dexmedetomidine) will receive nebulization with Dexmedetomidine 2mcg/kg diluted upto 4ml with normal saline 30 minutes before induction. Group L (Lignocaine) will receive nebulization with Lignocaine 4% solution,4mg/kg in 4ml normal saline 30minutes prior to induction. Randomisation will be done using computer-generated random numbers, and drug preparation will be performed by an anaesthesiologist not involved in outcome assessment. After pre-anaesthetic evaluation patient’s attendees will be counselled about the anaesthetic procedure and received in pre-operative room on the morning of surgery after confirming NPO status, recording of vitals parameters and IV line will be established and isolyte-P will be started using Holiday-Segar’s formula. Nebulization will be done by standard hospital portable nebuliser 15 minutes before induction.The baseline parameter like non-invasive blood pressure (NIBP) , electrocardiogram (ECG) , pulse rate , pulse oximetry (Spo2) , will be recorded before and after nebulization.

Patient will be shifted to the operating room theatre, all vital ASA standard monitors will be attached such as heart rate, non-invasive blood pressure, electrocardiogram, oxygen saturation and respiratory rate will be recorded. Standard method of anaesthesia will be used while inducing the patient. Premedication will be with midazolam 0.05 mg/kg, glycopyrrolate 0.04 mg/kg , induction will be with fentanyl 1mcg, propofol 2-3mg/kg and atracurium 0.5 mg/kg. Airway will be secured with an appropriate- sized airway device once the jaw is sufficiently relaxed. Size of endotracheal tube will be according to age and weight of the patient. Maintainence of anaesthesia is with O2+N2O (50:50%) and titrated sevofluorane with pressure-controlled ventilation,0.12 mg/kg atracurium at fixed intervals and maintainence of Etco2 between 35-45 mmhg. Neuromuscular blockade will be reversed with standard doses of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. After extubation , in the post anaesthesia care unit , FPS-R scale revised scoring will be recorded postoperatively. Emergence agitation will be assessed by (PAED) Pediatric Anaesthesia Emergence Delirium score and sedation will be assessed by using Modified Ramsay Sedation score. Time for oral intake will be noted . Patient will be receiving i.v. Paracetamol 10 mg/kg as rescue analgesia if requested and the total consumption of postoperative rescue analgesia will be recorded. Inj Dexamethasone 0.1 mg/kg will be used as second rescue analgesic.