Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000700831
Ethics application status
Approved
Date submitted
23/06/2012
Date registered
29/06/2012
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Role of oral ketamine and dexmedetomidine in adults burns dressing. A double blind randomised cross over study.
Scientific title
Role of oral ketamine and dexmedetomidine in adults burns dressing for evaluating safety and efficacy:A double blind randomised cross over study
Secondary ID [1] 280741 0
U1111 1127 5726
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 285720 0
Condition category
Condition code
Injuries and Accidents 285904 285904 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be given morphine intra muscular( IM) 0.1 mg/kg;; local anesthetic soaked gauzes will be applied on the wounds oral ketamine 5 mg/kg will be given ;visual analogue scale( VAS) score; sedation score; vital parameters will be recorded; the next day patient cross over to dexmedetomidine group; they will receive morphine similar to the previous day and dexmedetomidine 4ug/kg all the above parameters recorded
Intervention code [1] 284158 0
Treatment: Drugs
Comparator / control treatment
Ketamine compared with dexmedetomidine
Ketamine will serve as the control group
Control group
Active

Outcomes
Primary outcome [1] 286396 0
Analgesia during dressing assessed using VAS score
Timepoint [1] 286396 0
Before drug administration, after local anesthetic soaked gauzes, during cleaning and dressing every five minutes, end of procedure,2 hours after the procedure
Secondary outcome [1] 295775 0
Sedation effects using ramsay sedation score
Timepoint [1] 295775 0
Before the drug , after LA soaked gauzes, during cleaning and dressing every five minutes, end of the procedure ,2 hours after the procedure

Eligibility
Key inclusion criteria
adult patients with burns 20 to 50 % body surface area
Minimum age
15 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
facial burns preventing oral intake

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects after 48 hours of resuscitation will be included in the study if they satisfy the inclusion criteria they will be allocated into groups by sealed envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 4098 0
India
State/province [1] 4098 0
Puducherry

Funding & Sponsors
Funding source category [1] 285508 0
Self funded/Unfunded
Name [1] 285508 0
Country [1] 285508 0
India
Primary sponsor type
Hospital
Name
Jawaharlal Nehru institute of Medical education and research
Address
jipmer
Dhanvantri nagar
pondicherry 605006
Country
India
Secondary sponsor category [1] 284365 0
None
Name [1] 284365 0
Address [1] 284365 0
Country [1] 284365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287543 0
Jipmer ethics commitee
Ethics committee address [1] 287543 0
Jipmer hospital
Dhanvantri nagar
Pondicherry 605006
Ethics committee country [1] 287543 0
India
Date submitted for ethics approval [1] 287543 0
01/07/2010
Approval date [1] 287543 0
15/08/2010
Ethics approval number [1] 287543 0

Summary
Brief summary
To evaluate the analgesic effect and safety of dexmedetomidine and ketamine in adults during burns dressing changes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33709 0
Address 33709 0
Country 33709 0
Phone 33709 0
Fax 33709 0
Email 33709 0
Contact person for public queries
Name 16956 0
savitri velayudhan
Address 16956 0
savitri, dept of anesthesiology, jipmer,
dhanvantri nagar
pondicherry 605006
Country 16956 0
India
Phone 16956 0
+91 9994473345
Fax 16956 0
Email 16956 0
[email protected]
Contact person for scientific queries
Name 7884 0
savitri velayudhan
Address 7884 0
savitri
dept of anesthesiology

jipmer
dhanvantri nagar
pondicherry 605006
Country 7884 0
India
Phone 7884 0
+919994473345
Fax 7884 0
Email 7884 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.