| CTRI Number |
CTRI/2014/03/004456 [Registered on: 07/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Oral midazolam versus intranasal Dexmedetomidine for CT imaging in children |
|
Scientific Title of Study
|
Comparison of oral midazolam with intranasal Dexmedetomidine premedication for children undergoing CT imaging: randomized, double blind and controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MS/1467/Deptt./2762 version 1dated 22.12.2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Babita Ghai |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209533 |
| Fax |
0172-2744401 |
| Email |
ghaibabita@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babita Ghai |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209533 |
| Fax |
0172-2744401 |
| Email |
ghaibabita@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Babita Ghai |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209533 |
| Fax |
0172-2744401 |
| Email |
ghaibabita@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
CT Scan Room, Advanced pediatric Center, department of Radio diagnosis, PGIMER, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Babita Ghai |
Post Graduate Institute of Medical Education and Research |
Department of Anesthesia, PGIMER, Sector-12
Chandigarh
CHANDIGARH |
09914209533
0172-2744401
ghaibabita@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Postgraduate Institute of Medical Education And Research, Sector 12, Chandigarh-160012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pediatric patients visiting hospital for diagnostic CT Imaging , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine group (Group D) |
2.5 mc/Kg intranasal dexmedetomidine and oral honey 5 ml 20-30 minutes before venepuncture |
| Comparator Agent |
Midazolam group (group M) |
0.5 mg/Kg midazolam dissolved in 5 ml of honey orally and 1ml of sterile water intranasal 20-30 minutes before venepuncture |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
ASA I or II children aged 1 – 5 years scheduled for CT imaging under sedation |
|
| ExclusionCriteria |
| Details |
Children with history of allergy to eutectic mixture of local anesthetic (EMLA) cream, midazolam severe dysfunction of central nervous system, malformation of cardiovascular system, children on chronic hepatic enzyme inducing drugs or mentally retarded children |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of children requiring rescue sedation (IV ketamine) |
during CT Imaging |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of children crying at venipuncture, number of attempts at venipuncture, sedation and venipuncture scores, requirement of ketamine for CT, parental satisfaction, movements and motion artifacts during scan and requirement of repeat scan |
at venepuncture and during CT imaging |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
will be send for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Infants and children frequently require sedation to prevent motion artifacts during radiological imaging. We compared intranasal dexmedetomidine premedication (2.5mcg/kg) with oral midazolam 0.5 mg/kg for sedation in children undergoing CT imaging. Children were randomized to one of the two groups Group M received 0.5 mg/Kg midazolam and group D received 2.5 mc/Kg intranasal dexmedetomidine. After 20-30 minutes IV line was placed. The child was then transferred to CT table for imaging. Wilton score were observed and noted at that time. According to the level of sedation and scan duration, the child received 0.5 –1mg/Kg I.V ketamine to achieve a level of deep sedation. Any movement, motion artifact or repeat scans reported by radiologist were noted.
|