Our study aims to use dexmedetomidine in reduction of emergence delirium in children undergoing elective adenotonsillectomy after general anesthesia.
Design
This quasi experimental study was carried out at the Department of Anesthesiology, Combined Military Hospital from Jun-Dec 2023. A total of 90 patients (WHO minimum sample size 28) were included in the study keeping the confidence interval at 95%, power of test at 80%, with the proportion of children experiencing emergence delirium with per-operative dexmedetomidine infusion compared to placebo at 26% versus 60.8%10.
Settings and conduct
Double blinding where study group, resident and accessor were unaware.
Participants/Inclusion and exclusion criteria
Inclusion criteria included all ASA-I and II pediatric patients aged 6-12 years of age presenting in the pre-anesthesia clinic requiring general anesthesia fitness for elective adenotonsillectomy.
Exclusion criteria included patients with congenital anomalies, history if ICU admission in the last 3 months, advanced cardiac or respiratory disease, patients on anti-psychotics or mood stabilizers, allergic to dexmedetomidine and patients or their parents unwilling to be included in the study.
Intervention groups
Patients were divided into two groups as per the inclusion criteria and sampling technique specified. After being divided into two groups, Group D (n=45) to receive per-operative intravenous infusion of dexmedetomidine at 0.3 mcg/kg dilutes in 50 ml of normal saline over 5 minutes and Group P (n=45) to receive the placebo dosing of 50 ml normal saline over 5 minutes.
Main outcome variables
Primary variables studies were the total incidence of emergence delirium between both groups, median PAED (pediatric assessment emergence delirium) score .
Secondary variables measured were mean time to discharge and total dose of analgesia required post-operatively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240402061403N1
Registration date:2024-05-02, 1403/02/13
Registration timing:retrospective
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Dain Bin Khalid
Name of organization / entity
National University of Medical Sciences
Country
Pakistan
Phone
+92 324 4129326
Email address
dainbinkhalid7073@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-09-10, 1402/06/19
Actual recruitment start date
2023-06-14, 1402/03/24
Actual recruitment end date
2023-09-21, 1402/06/30
Trial completion date
2023-12-28, 1402/10/07
Scientific title
Role of Dexmedetomidine in reduction of Post-Operative Emergence Delirium in children undergoing Adenotonsillectomy
Public title
Reduction of Emergence Delirium In Children Undergoing Adenotonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA-I and II pediatric patients aged 6-12 years
Patients undergoing adenotonsillectomy under General Anaesthesia
Exclusion criteria:
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
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National University of Medical Sciences
Street address
Pak Emirates Military Hospital Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
529
Health conditions studied
1
Description of health condition studied
Emergence Delirium in children after undergoing Adenotonsillectomy in General Anesthesia
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
MEAN TOTAL DOSE OF ANALGESIA USED AND MEAN TOTAL RECOVERY TIME (TILL DISCHARGE)
Timepoint
(RECOVERY TILL DISCHARGE)
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Control group: Group P (n=45) received the placebo dosing of 50 ml normal saline over 5 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rawalpindi
Full name of responsible person
Dr Dain Bin Khalid
Street address
AMC Officers Mess Convoy Road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 324 4129326
Email
dainbinkhalid7073@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Dr Tufail Ahmed
Street address
National University of Medical Sciences The Mall Rawalpindi Pakistan
City
Rawalpindi
Postal code
49000
Phone
+92 322 8487073
Email
aqeel.yunus@numspak.edu.pk
Web page address
Grant name
NUMS Research Funding Program
Grant code / Reference number
1542
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National University of Medical Sciences
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Hafiz Arslan Arshad
Position
Resident Anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
AMC Officers Mess Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 6542119
Email
amcolian.arsy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Munim Ilyas
Position
Resident Anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
St#7 H #67 Bahria Town Phase 8 Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
48000
Phone
+92 51 6275449
Email
munimilyas@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Shujaat Hussain
Position
Resident Anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
AMC Officers Mess Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 6487335
Email
shujaat169@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Role of Dexmedetomidine in reduction of Post-Operative Emergence Delirium in children undergoing Adenotonsillectomy
When the data will become available and for how long
February 2025 to 1 year after publication
To whom data/document is available
All the residents and consultants working in Anesthesiology and Otorhinolaryngology
Under which criteria data/document could be used
documents can be used for similar researches for references and data and 1st two authors can be contacted via emails for access
From where data/document is obtainable
www.pafmj.org
What processes are involved for a request to access data/document
any of the authors including me can be contacted on email for data access