| CTRI Number |
CTRI/2018/03/012863 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of sedative drug and toys on anxiety in children |
|
Scientific Title of Study
|
comparison between premedication with intravenous midazolam and use of behavioral intervention to reduce preoperative anxiety in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandya Rani DC |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
62
1 st B cross
3 rd main
RMV 2nd stage chikkamaranahalli
Bangalore
Department of anaesthesia
M.S. Ramaiah medical college
MSR Nagar
MSRIT Post
Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9886127243 |
| Fax |
|
| Email |
drsandyarani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandya rani DC |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
no 62
1 st B cross
3 rd main
RMV 2nd stage
Chikkamaranahalli
Bangalore
Department of anaesthesia
M S Ramaiah medical college
MSR Nagar
MSRIT Post
Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9886127243 |
| Fax |
|
| Email |
drsandyarani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandya Rani DC |
| Designation |
Assistant Professor |
| Affiliation |
M S Ramaiah Medical College |
| Address |
62
1 B cross
3 main
RMV @ stage
Chikkamaranahalli
Bangalore
Department of anaesthesia
M S Ramaiah medical college
MSR Nagar
MSRIT post
Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9886127243 |
| Fax |
|
| Email |
drsandyarani@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah medical college
MSR Nagar
MSRIT Post
Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
msramaiah medical college and hospitals |
| Address |
m s ramaiah medical college, msr nagar bangalore 560054 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandya Rani D C |
Department of anesthesiology |
M S Ramaiah Hospital
MSR Nagar
MSRIT Post
Bangalore 560054
Bangalore
KARNATAKA |
9886127243
drsandyarani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| m s ramaiah medical college and hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
posted for elective surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group B: these children will receive behavioral intervention
Group M: these children will not receive behavioral intervention and will receive intravenous midazolam.
|
All children will be visited on the preoperative day for pre anaesthetic evaluation by a consultant or resident who will anaesthetize the child next day. Children in the behavioral intervention group will be given a basket of toys. They will be allowed to select toy of their choice. They will also be given circuits and masks for familiarization. They will be thought how to breathe through the circuit. Children in the midazolam group will not be given any toys after pre anesthetic evaluation. Intravenous line will be placed for all children in the wards.
On the day of surgery after the children are shifted to pre anaesthetic area modified yale pre operative anxiety scale (mYPAS) Appendix 1 will be recorded in both the groups. Children in behavioral intervention group will be given toys and allowed to play with them. Children in the midazolam group will receive intravenous midazolam 0.1mg/kg. After 10 mins mYPAS score will be recorded in both the groups and the children will be shifted to operation theater. The last mYPAS score will be recorded just before induction of anaesthesia.
|
| Intervention |
group M: these children will receive intravenous midazolam |
All children will be visited on the preoperative day for pre anaesthetic evaluation by a consultant or resident who will anaesthetize the child next day. Children in the behavioral intervention group will be given a basket of toys. They will be allowed to select toy of their choice. They will also be given circuits and masks for familiarization. They will be thought how to breathe through the circuit. Children in the midazolam group will not be given any toys after pre anesthetic evaluation. Intravenous line will be placed for all children in the wards. On the day of surgery after the children are shifted to pre anaesthetic area modified yale pre operative anxiety scale (mYPAS) Appendix 1 will be recorded in both the groups. Children in behavioral intervention group will be given toys and allowed to play with them. Children in the midazolam group will receive intravenous midazolam 0.1mg/kg. After 10 mins mYPAS score will be recorded in both the groups and the children will be shifted to operation theater. The last mYPAS score will be recorded just before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
children between 3 to 9 years of ASA 1 and 2 posted for elective minor surgeries |
|
| ExclusionCriteria |
| Details |
children below 3 years and above 9 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of behavioral intervention program by giving toys and the effects with premedication with intravenous midazolam reduce anxiety in children preoperatively |
10 minutes and 20 minutes after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative sedation |
10 minutes after surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2016 |
| Date of Study Completion (India) |
22/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All
children fulfilling the inclusion criteria will be visited on the preoperative day for pre anaesthetic evaluation
by a consultant or resident who will anaesthetize the child next day. Children
in the behavioral intervention group will be given a basket of toys. They will
be allowed to select toy of their choice. They will also be given circuits and
masks for familiarization. They will be thought how to breathe through the
circuit. Children in the midazolam group will not be given any toys after pre
anesthetic evaluation. Intravenous line will be placed for all children in the
wards.
On
the day of surgery after the children are shifted to pre anaesthetic area
modified yale pre operative anxiety scale (mYPAS) Appendix 1 will be recorded
in both the groups. Children in behavioral intervention group will be given
toys and allowed to play with them. Children in the midazolam group will
receive intravenous midazolam 0.1mg/kg. After 10 mins mYPAS score will be
recorded in both the groups and the children will be shifted to operation
theater. The last mYPAS score will be recorded just before induction of
anaesthesia. |