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IRCT20240402061403N1 IRCT 2024-05-02 National University of Medical Sciences Reduction of Emergence Delirium In Children Undergoing Adenotonsillectomy Role of Dexmedetomidine in reduction of Post-Operative Emergence Delirium in children undergoing Adenotonsillectomy 2023-06-10 anticipated 100 Complete https://irct.ir/trial/76226 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The resident on duty received pre-made burettes marked X or Y in one of the two groups without knowledge of the drug or dose titration and unaware of the study protocol. To prevent bias, patients were also not made aware of which group was to receive the drug and which was to receive placebo. The drugs were prepared by an independent consultant in the recovery room and result complied by the resident were handed over to a third consultant involved in data analysis. N/A Emergence Delirium in children after undergoing Adenotonsillectomy in General Anesthesia. Intervention 1: Intervention group: Group D (n=45) received per-operative intravenous infusion of dexmedetomidine at 0.3 mcg/kg dilutes in 50 ml of normal saline over 5 minutes. Intervention 2: Control group: Group P (n=45) received the placebo dosing of 50 ml normal saline over 5 minutes. Yes - There is a plan to make this available What will be shared: Role of Dexmedetomidine in reduction of Post-Operative Emergence Delirium in children undergoing Adenotonsillectomy When: February 2025 to 1 year after publication To whom: All the residents and consultants working in Anesthesiology and Otorhinolaryngology Conditions: documents can be used for similar researches for references and data and 1st two authors can be contacted via emails for access Where to obtain: www.pafmj.org How to obtain: any of the authors including me can be contacted on email for data access Comments:
public Hafiz Arslan Arshad
AMC Officers Mess Rawalpindi
Rawalpindi Pakistan 46000 +92 51 6542119 amcolian.arsy@gmail.com National University of Medical Sciences scientific Munim Ilyas
St#7 H #67 Bahria Town Phase 8 Rawalpindi
Rawalpindi Pakistan 48000 +92 51 6275449 munimilyas@gmail.com National University of Medical Sciences Pakistan ASA-I and II pediatric patients aged 6-12 years Patients undergoing adenotonsillectomy under General Anaesthesia 6 years 12 years Both Patients with congenital anomalies, History of ICU admission in last 3 months Cardiac or respiratory disease Patients on anti psychotics and mood stabilizers Allergic to dexmedetomidine Patients unwilling to be included in the study F05 Delirium due to known physiological condition Treatment - Drugs Placebo Intervention group: Group D (n=45) received per-operative intravenous infusion of dexmedetomidine at 0.3 mcg/kg dilutes in 50 ml of normal saline over 5 minutes Control group: Group P (n=45) received the placebo dosing of 50 ml normal saline over 5 minutes. Incidence of emergence delirium between the two groups who were administered dexmedetomidine and placebo. Timepoint: Pre-Operatively, Post-Operatively at 30 minutes and 1 hour. Method of measurement: PAED (pediatric assessment emergence delirium) score and Watcha delirium score. MEAN TOTAL DOSE OF ANALGESIA USED AND MEAN TOTAL RECOVERY TIME (TILL DISCHARGE). Timepoint: (RECOVERY TILL DISCHARGE). Method of measurement: Visual Analogue Scale. National University of Medical Sciences Approved 2023-06-06 National University of Medical Sciences Pak Emirates Military Hospital Rawalpindi Rawalpindi Punjab Pakistan