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CTRI Number  CTRI/2024/02/062865 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Emergence Delirium in children and its effect on quality of life and length of hospital stay 
Scientific Title of Study   A Study to assess the prevalence of pediatric anesthesia emergence delirium and its effect on quality of life and length of hospital stay among children of 2-15 years in the post operative units of AIIMS, Bhubaneswar 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishnendu S 
Designation  MSc. Nursing Student 
Affiliation  AIIMS Bhubaneswar 
Address  College Of Nursing, AIIMS Bhubanswar, Sijua,Patrapada, PO-Dumduma, Odisha

Khordha
ORISSA
751019
India 
Phone  9560516712  
Fax    
Email  kskrishna2303@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Asha P Shetty 
Designation  Professor-cum-Principal 
Affiliation  AIIMS Bhubaneswar 
Address  Room Number-109, College Of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, PO-Dumduma, Odisha

Khordha
ORISSA
751019
India 
Phone  9448770302  
Fax    
Email  nurs_asha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. Asha P Shetty 
Designation  Professor-cum-Principal 
Affiliation  AIIMS Bhubaneswar 
Address  Room Number-109, College Of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, PO-Dumduma, Odisha


ORISSA
751019
India 
Phone  9448770302  
Fax    
Email  nurs_asha@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha 751019 
 
Primary Sponsor  
Name  College of Nursing 
Address  College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Odisha 751019 
Type of Sponsor  Other [College of Nursing] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditya Arvind Manekar  AIIMS Bhubaneswar  OT-1 and OT-2, Post-operative Units, 4th Floor, Department of Pediatic Surgery, AIIMS Bhubaneswar, Sijua, Patrapada, Odisha 751019
Khordha
ORISSA 		 8850540210

pedsurg_aditya@aimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children of the age 2-15 years, who are undergoing any surgical interventions involving general anesthesia and those who are admitted in the post operative units of AIIMS, Bhubaneswar.
Parents or caregiver who gave the informed consent.
 
 
ExclusionCriteria 
Details  1. Children with parents not willing to participate in the study
2. Children with history of cognitive or neurological disturbances
3. children who are intubated in the post-operative period
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Pediatric Anesthesia Emergence Delirium post operatively  First 60 minutes following awakening of child in post-operative unit 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life and length of hospital stay for the children of 2-15 years  After surgery till Discharge followed by 1 month duration 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/02/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study is a cross-sectional study to assess the prevalence of pediatric anesthesia emergence delirium and its effect on quality of life and length of hospital stay among children of 2-15 years in the post-operative units of AIIMS Bhubaneswar.
The study will be conducted in the pediatric post-operative units of AIIMS, Bhubaneswar.
The study is to assess the prevalence of emergence delirium among children in the post operative period and evaluate the quality of life. The child is observed every 15 minutes for first 60 minutes following awakening in the post-operative unit to assess the prevalence of emergence delirium and from the day of surgery till the day of discharge from hospital is analyzed for duration of hospital stay. While the quality of life is assessed pre-operatively and a month following surgery with the PedsQL Generic Core Scale.
Prior permission will be obtained from the Principal, College of Nursing, the Medical Superintendent, and the H.O.D./Unit, Bhubaneswar. Informed consent will be taken from parents and confidentiality will be maintained throughout the study.
 
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