| CTRI Number |
CTRI/2018/04/013123 [Registered on: 09/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a comparative evaluation of intranasal dexmedetomidine vs midazolam for preoperative sedation in children |
|
Scientific Title of Study
|
A Comparative Evaluation Of Intranasal Dexmedetomidine & Intranasal Midazolam For Premedication In Children A Double Blind Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arcojit Ghosh |
| Designation |
Post Graduate Trainee |
| Affiliation |
R G Kar Medical College & Hospital Kolkata |
| Address |
Department of Pharmacology
R G Kar Medical College and Hospital
Kolkata
Kolkata WEST BENGAL 700004 India |
| Phone |
9830245087 |
| Fax |
|
| Email |
arcojitg@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Asoke Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
R G Kar Medical College & Hospital Kolkata |
| Address |
Department of Pharmacology
R G Kar Medical College & Hospital
Kolkata
Kolkata WEST BENGAL 700004 India |
| Phone |
9733050609 |
| Fax |
|
| Email |
dr.askd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Arcojit Ghosh |
| Designation |
post graduate trainee |
| Affiliation |
r g kar medical college & hospital kolkata |
| Address |
department of Pharmacology
R G Kar Medical College
Kolkata-700004
South Twentyfour Parganas WEST BENGAL 700084 India |
| Phone |
9830245087 |
| Fax |
|
| Email |
arcojitg@gmail.com |
|
|
Source of Monetary or Material Support
|
| R G Kar Medical College & Hospital
Kolkata-700004 |
|
|
Primary Sponsor
|
| Name |
R G Kar Medical College Hospital Kolkata |
| Address |
R G Kar Medical College & Hospital
1 Khudiram Bose Sarani
kolkata 4 |
| Type of Sponsor |
Government 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 |
| Arcojit Ghosh |
R G Kar Medical College & Hospital, Kolkata |
Recovery room for Pediatric Surgery OT, functioning under Department of Anesthesiology
8th floor, emergency building, R G Kar Medical College & Hospital Kolkata WEST BENGAL |
9830245087
arcojitg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| r g kar medical college & hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All children belonging to ASA 1 health status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine |
100 mcg/ml vials used. drug was diluted to desirable doses using distilled water.
dose used in this study 2 mcg/kg |
| Comparator Agent |
midazolam |
5 mg/ml vials were used. drug was diluted to desirable doses by distilled water.
dose used was 0.5 mg/kg |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 2-8 yrs belonging to ASA physical status I or II scheduled for elective surgery |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| satisfactory sedation score achieved at the time of induction |
45 mins after administration of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/04/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
OBJECTIVES:
The study aimed at comparing the efficacies of intranasal dexmedetomidine &
intranasal midazolam regarding producing sedation at induction. The secondary
end- points were preoperative heart rate & systolic bloos pressure changes
after administration of either drugs. We also looked at sedation &
analgesia status at the time of induction, recovery as well as 3 hours & 6
hours post operatively. METHODS:
Study subjects comprised of children aged 2-8 years posted for elective surgery
under general anesthesia. It was a double blind randomized control trial
comprising of 90 subjects divided into 2 groups. group A (n=42) received 0.2
μg/kg dexmedetomidine & group B (n=48) 0.5 mg/kg midazolam by intranasal
route 45 minutes prior to induction. sedation & analgesia scores were
assessed by Ramsay Sedation Scale & Observer Pain Scale respectively. heart
rate & systolic blood pressures were recorded every 15 minutes pre-
operatively after administration of drugs. sedation & analgesia scores were
recorded at induction, recovery, after 3 hours & 6 hours post operatively. RESULTS:
93% subjects in group A & 60% in group B achieved satisfactory sedation at
the time of induction. Sedation status & analgesia obtained at the time of
induction, recovery, 3 hours & 6 hours post operatively were significantly
better in group A. Pre- operative changes in HR & SBP in both groups were
comparable.
CONCLUSION:
Intranasal dexmedetomidine is safe &more effective
than intranasal midazolam for pre operative sedation in children. Also,
intranasal dexmedetomidine is a superior agent than intranasal midazolam for
post operative analgesia in pediatric population. |