The objective of this research was to assess the effectiveness of oral promethazine in comparison to intranasal midazolam in terms of its sedative and anxiolytic effects prior to anesthesia in children.
Design
Single center two arm parallel group randomized control trial of 100 participants with pre operative care and outcome assessment
Settings and conduct
This is a non- blinded randomized control trial done at department of anaesthesiology, Combined Military Hospital Rawalpindi, after approval from the ethical board committee
Participants/Inclusion and exclusion criteria
Children between ages 2-6 years, of either gender, undergoing elective surgery were included in the present study. Children with respiratory issues, known allergies, and required intravenous anesthesia were excluded from the present study.
Intervention groups
Two intervention groups: group M, which received intranasal midazolam at a dosage of 0.3 mg/kg, administered 30 minutes before the start of general anesthesia induction, and group P, which received oral promethazine syrup at a dosage of 1 mg/kg, administered 90 minutes before the start of general anesthesia induction.
Main outcome variables
The assessment of the patient's sedation and emotional levels will be conducted using a five-point sedation scale and a four-point emotional scale. The study also includes the examination of heart rate, respiratory rate, and oxygen saturation % to assess the effect of intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059228N1
Registration date:2023-09-12, 1402/06/21
Registration timing:registered_while_recruiting
Last update:2023-09-12, 1402/06/21
Update count:0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Nasar ul Islam Zakria
Name of organization / entity
College of Physicians and Surgeons Pakistan
Country
Pakistan
Phone
+92 314 4490074
Email address
nasarulislam1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-30, 1402/03/09
Expected recruitment end date
2023-11-30, 1402/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral promethazine administered pre operatively in relieving anxiety in paediatric patients undergoing surgery under general anaesthesia
Public title
Promethazine for relieving anxiety in pre operative children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children between ages 2-6 years
Both genders
Those undergoing elective surgery
Those undergoing surgeries under general anaesthesia
Exclusion criteria:
Children with respiratory issues
Those with known allergies
Those requiring intravenous anesthesia
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with unit of randomization being the individual participant. Participants will be randomly assigned to either intervention group 1 or intervention group 2, with a 1:1 allocation as per a computer generated randomisation schedule using blocks of random sizes. Allocation concealment not to be carried out
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of CMH Rawalpindi
Street address
CMH Road, Lalkurti
City
Rawalpindi
Postal code
46000
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
444
Health conditions studied
1
Description of health condition studied
Pre operative anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Pre operative anxiety
Timepoint
30, 25, 20, 15, 10, and 5 minutes before the scheduled delivery of general anesthesia.
Method of measurement
Five-point sedation scale, a four-point emotional scale, heart rate, respiratory rate and oxygen saturation %
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Children in group M, which received intranasal midazolam at a dosage of 0.3 mg/kg, administered 30 minutes before the start of general anesthesia induction.
Category
Treatment - Drugs
2
Description
Intervention group 2 : Children in group P, which received oral promethazine syrup at a dosage of 1 mg/kg, administered 90 minutes before the start of general anesthesia induction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital, Rawalpindi
Full name of responsible person
Dr Aqib Ali
Street address
CMH Road, Lalkurti
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
nasarulislam1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Dr Aqib Ali
Street address
CMH Road, Lalkurti
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
nasarulislam1995@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi
Proportion provided by this source
100
Public or private sector
Public
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
Combined Military Hospital Rawalpindi
Full name of responsible person
Dr Aqib Ali
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road, Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
nasarulislam1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Dr Aqib Ali
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road, Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
nasarulislam1995@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital
Full name of responsible person
Dr Aqib Ali
Position
Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
CMH Road, Lalkurti
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
nasarulislam1995@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available