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Trial registered on ANZCTR


Registration number
ACTRN12619000555156p
Ethics application status
Submitted, not yet approved
Date submitted
8/03/2019
Date registered
9/04/2019
Date last updated
9/04/2019
Date data sharing statement initially provided
9/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine versus nitrous oxide plus intranasal fentanyl for paediatric fracture reduction in the emergency department: a prospective randomised comparison trial
Scientific title
Ketamine versus nitrous oxide plus intranasal fentanyl for paediatric fracture reduction in the emergency department: a prospective randomised comparison trial
Secondary ID [1] 297580 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric fractures requiring manipulation / reduction
 311836 0
Condition category
Condition code
Emergency medicine 310434 310434 0 0
Other emergency care
Injuries and Accidents 310435 310435 0 0
Fractures
Anaesthesiology 310436 310436 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nitrous oxide (N2O) plus intranasal fentanyl (INF) treatment group
This treatment requires a Nurse Practitioner, Registrar or consultant physician.
Patients randomised to this group will be given INF 2 µg/kg via laryngeal mask airway (LMA) Intranasal mucosal atomization device 15 mins prior to the procedure. Inhalation N2O will commence via a Matrix Digital mobile device management (MDM) delivery mixer starting at 50% N2O and titrated to a concentration of 70% N2O over 5 mins prior to procedure. This slow titration of N2O decreases the incidence of vomiting using N2O in combination with INF.

Ketamine procedural sedation and analgesia (PSA) treatment group
For the ketamine sedation a consultant physician, or registrar under the direction of a consultant physician, will be present at the bed side for the procedural sedation.
Patients randomised to receive ketamine for PSA will receive an initial dose of 1 to 2 mg/kg IV Ketamine prior to commencement of the procedure. Dose of ketamine provided will be decided by clinician discretion. Topical EMLA (lidocaine 2.5% and prilocaine 2.5%) will be used at the site of injection at least 30 mins prior to IV cannulation to reduce pain at the injection site. Subsequent titrated doses of IV ketamine (0.3 to 0.5 mg/kg) may be administered during the procedure, as deemed necessary by the administering clinician.
Intervention code [1] 313812 0
Treatment: Drugs
Comparator / control treatment
The Ketamine PSA treatment group is the current standard of care (active control).
Control group
Active

Outcomes
Primary outcome [1] 319305 0
The primary outcome of this study will be parental satisfaction with the procedure between treatment groups, measured using a scale from 0 (= very bad) to 10 (= excellent).
Timepoint [1] 319305 0
Following the conformation X-ray
Primary outcome [2] 319386 0
Overall judgement on the child’s experience will be further assessed using a validated, satisfaction questionnaire adapted to the ED setting (Iacobucci T et al., 2005). This questionnaire investigates several areas: quality of care provided by the clinical staff involved in the procedure, parental opinion of the child’s recollection and parental opinion of the overall experience. Satisfaction is a score of 6 or above on the Likert scale.
Timepoint [2] 319386 0
Following the conformation X-ray
Secondary outcome [1] 367658 0
The child’s perception of their pain experienced during the procedure will be assessed using a modified Visual Analogue Scale (VAS) with faces and a scale from 0 (= no pain) to 10 (= worst pain).
Timepoint [1] 367658 0
At ED discharge
Secondary outcome [2] 369095 0
Child behaviour prior to and during the procedure will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) score
Timepoint [2] 369095 0
Prior to and during the procedure
Secondary outcome [3] 369096 0
The Modified Observer’s Assessment of Alertness scale will be used to evaluate the level of sedation
Timepoint [3] 369096 0
Level of sedation will be recorded at regular intervals throughout the treatment.
Secondary outcome [4] 369097 0
An economic evaluation of staffing costs associated with both treatment methods will be undertaken.
Timepoint [4] 369097 0
Treating staff will be documented on the data collection sheet.
Secondary outcome [5] 369144 0
Patient length of stay will be used to perform an economic evaluation of each treatment
Timepoint [5] 369144 0
Time stamps will be taken throughout the patients stay in ED
Secondary outcome [6] 369145 0
Success of the procedure will be assessed by asking the clinician if the reduction achieved is adequate for patient disposition from ED.
Timepoint [6] 369145 0
Following the conformation X-ray
Secondary outcome [7] 369146 0
Any sedation-related adverse events requiring medical intervention to correct deranged physiology, resulting abandonment of the procedure, requiring a prolonged ED admission or an unplanned admission to hospital will be recorded in accordance with the consensus panel on sedation research of both the Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN)
Timepoint [7] 369146 0
Throughout patient stay in ED

Eligibility
Key inclusion criteria
Inclusion criteria will comprise the following: patients aged 2 – 17 with closed limb or extremity fractures requiring reduction and manipulation.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be patients with multi-system trauma, head injury with altered level of consciousness or behavioural changes of known intolerance / severe allergy to fentanyl, N2O or ketamine.

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 will be concealed by using randomisation and sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation will be carried out using Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13289 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 25860 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 302128 0
Hospital
Name [1] 302128 0
Redcliffe Hospital, in kind support
Country [1] 302128 0
Australia
Primary sponsor type
Individual
Name
David Bishop
Address
Redcliffe Hospital Emergency Department,
Anzac Avenue,
Redcliffe,
QLD 4020
Country
Australia
Secondary sponsor category [1] 301965 0
Individual
Name [1] 301965 0
Erik Wood
Address [1] 301965 0
Redcliffe Hospital Emergency Department,
Anzac Avenue,
Redcliffe,
QLD 4020
Country [1] 301965 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302811 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 302811 0
Ethics committee country [1] 302811 0
Australia
Date submitted for ethics approval [1] 302811 0
11/12/2018
Approval date [1] 302811 0
Ethics approval number [1] 302811 0

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

Contacts
Principal investigator
Name 91474 0
Mr David Bishop
Address 91474 0
Redcliffe Hospital Emergency Department,
Anzac Avenue,
Redcliffe,
QLD 4020
Country 91474 0
Australia
Phone 91474 0
+61 432 767 496
Fax 91474 0
Email 91474 0
David.Bishop@health.qld.gov.au
Contact person for public queries
Name 91475 0
David Bishop
Address 91475 0
Redcliffe Hospital Emergency Department,
Anzac Avenue,
Redcliffe,
QLD 4020
Country 91475 0
Australia
Phone 91475 0
+61 432 767 496
Fax 91475 0
Email 91475 0
David.Bishop@health.qld.gov.au
Contact person for scientific queries
Name 91476 0
Erik Wood
Address 91476 0
Redcliffe Hospital Emergency Department,
Anzac Avenue,
Redcliffe,
QLD 4020
Country 91476 0
Australia
Phone 91476 0
+61 412 730 459
Fax 91476 0
Email 91476 0
Erik.Wood@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.