Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001138976
Ethics application status
Approved
Date submitted
3/11/2019
Date registered
2/11/2020
Date last updated
2/11/2020
Date data sharing statement initially provided
2/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Hematoma block in acute pain management and closed reduction of fractures in children presenting to DHQ Kohat: An exploratory RCT
Scientific title
Effectiveness of Hematoma block in acute pain management and closed reduction of fractures in children presenting to DHQ Kohat: An exploratory RCT
Secondary ID [1] 299678 0
None
Universal Trial Number (UTN)
U1111-1242-7713
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractures 315028 0
Condition category
Condition code
Injuries and Accidents 313358 313358 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hematoma block and intravenous analgesia are the two interventions which will be administered by the Surgeon. Patients will be randomized to one of the groups. Each patient will only recieve one intervention.
The intervention will be administered immediately before the fracture reduction.

Hematoma block: Fracture hematoma will be injected with 2% lignocaine in a dose of 0.5 ml/kg.

Intravenous analgesia: Injection Ketorolac (Toradol) will be injected in the Cubital vein of the contralateral limb in a dose of 0.2 ml/kg.
Intervention code [1] 315943 0
Treatment: Drugs
Comparator / control treatment
Hematoma block is the comparator treatment.
Hematoma block is not compared with Intravenous analgesia in children with fractures of lower segment of limbs before.

Hematoma block will be done in emergency department of KMU-Institute of medical sciences (DHQ Teaching Hospital), Kohat.
The hematoma block will be delivered only once. 2 % (lignocaine) xylocaine solution in a dose of 0.2 ml per kg weight will be used for hematoma block.
Control group
Active

Outcomes
Primary outcome [1] 321861 0
To evaluate the effectiveness of hematoma block versus intravenous analgesia in acute pain management of fractures of forearm and shin bones in children.

Pain assessment will be done by using a visual analogue scale.
Timepoint [1] 321861 0


Pain assessment on visual analogue scale will be done, 5 minutes after administration of Hematoma block/Intravenous analgesia.

Pain assessment on visual analogue scale -30 minutes after administration of Hematoma block/IVA.
Secondary outcome [1] 376517 0
To evaluate the effectiveness of hematoma block and intravenous analgesia in closed reduction of fractures of forearm and shin bones in children
Timepoint [1] 376517 0
The reduction will be assessed by orthopedic surgeon for alingment. This will be done immediately after the reduction process is completed.
Pre and post reduction X-rays will be used for this purpose.

Eligibility
Key inclusion criteria
Age between 7-14 years. Simple/closed fracture pattern.
Fractures of the forearm or shin bone.
Fracture duration less than 24 hours.
Parents Consent.
Childs Assent.
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with any co morbid disease, intra-articular, and epiphyseal fractures.

Un-displaced forearm and shin bone fractures which do not require manipulation.

Patients with multiple fractures.

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)
Allocation concealment will be done and sealed opaque envelopes will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
By taking the mean difference -0.32 in two groups (Fatih 2015), keeping 95% of CI and 80% of power the total sample size will be 150 with 75 in each group.

Study data will be entered and analyzed in SPSS version 22.0 for statistical analysis.
Descriptive data will be compared between the two groups. Ordinal and categorical data will be compared using the chi-square test.
Differences will be considered significant at P < 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/11/2019
Date of last participant enrolment
Anticipated
30/11/2020
Actual
Date of last data collection
Anticipated
30/11/2020
Actual
Sample size
Target
150
Accrual to date
121
Final
Recruitment outside Australia
Country [1] 22004 0
Pakistan
State/province [1] 22004 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 304173 0
Self funded/Unfunded
Name [1] 304173 0
Country [1] 304173 0
Primary sponsor type
Individual
Name
Khalid Rehman
Address
Institute of Public Health & Social Sciences. Khyber Medical University. Phase V Hayatabad. Peshawar.
Country
Pakistan
Secondary sponsor category [1] 304403 0
None
Name [1] 304403 0
Address [1] 304403 0
Country [1] 304403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304633 0
Ethics committee of Khyber Medical University.
Ethics committee address [1] 304633 0
Ethics committee country [1] 304633 0
Pakistan
Date submitted for ethics approval [1] 304633 0
07/10/2019
Approval date [1] 304633 0
11/11/2019
Ethics approval number [1] 304633 0
DIR/KMU-EB/EII/000699

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97658 0
A/Prof Tauseef Raza.
Address 97658 0
District headquarter hospital Kohat.
Kohat Development Authority. Pakistan.
PO BOX 26000.
Country 97658 0
Pakistan
Phone 97658 0
+92 922 514 564
Fax 97658 0
Email 97658 0
[email protected]
Contact person for public queries
Name 97659 0
Khalid Rehman
Address 97659 0
Institute of Public Health & Social Sciences. Phase V. Hayatabad.
Khyber Medical University. Peshawar. PO BOX 25100
Country 97659 0
Pakistan
Phone 97659 0
+92 91 5892867
Fax 97659 0
Email 97659 0
[email protected]
Contact person for scientific queries
Name 97660 0
Khalid Rehman
Address 97660 0
Institute of Public Health & Social Sciences. Phase V. Hayatabad.
Khyber Medical University. Peshawar. PO BOX 25100
Country 97660 0
Pakistan
Phone 97660 0
+92 91 5892867
Fax 97660 0
Email 97660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
From the demography, age and gender will be available.
type of fracture.
Visual analogue scale assessment.
When will data be available (start and end dates)?
Start date: 1st June 2020
End date: No end date determined.
Available to whom?
Only researchers who provide a sound justification for the need of the data.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
This data will be made available by email, once the PI recieve any email about this. Email ID: [email protected]


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.