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Trial registered on ANZCTR


Registration number
ACTRN12619001647123p
Ethics application status
Not yet submitted
Date submitted
23/10/2019
Date registered
26/11/2019
Date last updated
4/03/2020
Date data sharing statement initially provided
26/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The DAFF Study – Direct Current Cardioversion for acute onset Atrial Fibrillation in the Emergency department and the need for Fentanyl.
Scientific title
Multi-centre prospective randomised placebo-controlled study to evaluate the role of Intravenous Fentanyl during DC cardioversion for the treatment of acute onset Atrial fibrillation. (DAFF Study – Direct Current Cardioversion, Atrial Fibrillation and Fentanyl use)
Secondary ID [1] 294794 0
None
Universal Trial Number (UTN)
Trial acronym
DAFF Study – Direct Current Cardioversion, Atrial Fibrillation and Fentanyl use
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 314927 0
Condition category
Condition code
Emergency medicine 313282 313282 0 0
Resuscitation
Cardiovascular 313523 313523 0 0
Other cardiovascular diseases
Anaesthesiology 313524 313524 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study population: Patients presenting to Emergency Department (ED) >18 years of age with:
- Atrial Fibrillation < 48 hours duration (defined by irregularly irregular narrow complex tachyarrythmia on electrocardiogram) considered suitable for Direct Current Cardioversion within the ED.
Patients will be randomised to receive (Intervention) Fentanyl 1microgram/kg intravenously at the commencement of the procedure. Patients enrolled in the Control arm will receive an identical volume of Normal saline intravenously at the commencement of the procedure.
Intervention code [1] 315879 0
Treatment: Drugs
Comparator / control treatment
Both groups will undergoe procedural sedation to facilitate DC cardioversion in the ED.

Comparator group: Conventional Procedural sedation with full cardiorespiratory monitoring.
Procedural sedation will be delivered by appropriately credentialled Emergency medical staff and include:
1) up to 1 mcg/kg bolus FENTANYL - Fentanyl to be reconstituted 100micrograms in 10mls N/saline. Dose up to 0.1ml/kg. Maximum dose 100mcg Fentanyl.
2) Propofol titrated to effect.

Control group: Conventional Procedural sedation with full cardiorespiratory monitoring.
Procedural sedation will be delivered by appropriately credentialled Emergency medical staff and include:
1) up to 0.1 ml/kg bolus of N/saline (placebo) Maximum dose 10mls.
2) Propofol titrated to effect.
Control group
Placebo

Outcomes
Primary outcome [1] 321770 0
The response to the scripted question “Do you need immediate treatment for any pain that you are experiencing?” when patient has emerged from sedation to a point where the patient is able to state their name (T0). A repeat observation of pain perception will be made 10 minutes after this point (T10). At each point , participants will also be asked to rate their perception of pain an a likert scale.

Timepoint [1] 321770 0
The requirement for pain relief at T0 ( when the patient can state their name) and at T10 (10 minutes post emergence).
Secondary outcome [1] 376161 0
Reversion rate to Sinus Rhythm as determined by the post cardioversion Electrocardiogram


Timepoint [1] 376161 0
Within 30 minutes of the commencement of Procedural sedation
Secondary outcome [2] 376857 0
The incidence of clinically relevant apnea and rate of use of assisted ventilation including but not limited to Bag Valve Mask (BVM) Ventilation.
Clinically relevant apnea is defiend as:
Any signs of apnea (e.g., more apnea than would be expected for a “clinical circumstance”) that meets one of the following criteria:
a. Requiring medical intervention by a health care professional
b. Leading to hospitalization or increased level of care
c. Prompting face to face evaluation by a health care professional

The frequency of Clinically relevant apnoea will be directly observed. At the conclusion of the procedural sedation, the Clinician supervising will be required to complete an observation sheet . A check box list will be included on that sheet which is the same as the criteria above.
Timepoint [2] 376857 0
Within 30 minutes of the commencement of Procedural sedation any signs of apnea (e.g., more apnea than would be expected for a “clinical circumstance”) that meets one of the following criteria:
a. Requiring medical intervention by a health care professional
b. Leading to hospitalization or increased level of care
c. Prompting face to face evaluation by a health care professional
Secondary outcome [3] 376861 0
Haemodynamic instability defined as: Sinus tachycardia HR > 120, Systolic BP< 90 mmHg, SaO2 <90%)
At the conclusion of the procedural sedation, the Clinician supervising will be required to complete an observation sheet . A check box list will be included on that sheet which is the same as the criteria above. The haemodynamic record of the procedure will be studied to complete this data.
Timepoint [3] 376861 0
Within 30 minutes of the commencement of the Procedural sedation the clinical record will be reviewed.

Eligibility
Key inclusion criteria
Adult patients (Age >18 year)
Able to provide informed consent to enrol in study
Atrial fibrillation deemed clinically appropriate for DC cardioversion using procedural sedation and analgesia.
No allergy to Propofol or Fentanyl
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal of consent
Allergy to Fentanyl or Propofol
Dose of intravenous fentanyl in the preceding 2 hours prior to procedure
Atrial fibrillation duration unknown
Intercurrent Monoamine Oxidase inhibitor use
Pregnancy
Severe Impariment of Pulmonary reserve
Hepatic failure
Renal failure

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)
Randomised at time of enrollment through randomly allocated envelope which containts the treatement directive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation at time of enrolment using randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
An ED Nurse not directly related to the case will read the directive and will either draw up 10 mls N/saline ( Placebo) or 100micrograms of Fenatyl (10mcg/ml) to a total volume of 10 mls N/saline.
Placebo and active drug will have identical appearance and will provided to clinicians.
The dose administered of either solution will be 0.1ml /kg body weight to a maximum of 10mls.
Staff will sign S8 register as usual when active drug is taken from the medication/drug room, but will not sign if Fentanyl is not drawn up.The Nurse responsible for drawing up the syringe will ensure that it is used and disposed of (complying with existing S8 legislation).
Master register will be kept confidential to maintain blinding..
The placebo used is normal saline (0.9% NaCl) in a 10ml Syringe. The active drug (intervention) is Fentanyl 100mcg in a 10ml Syringe.

At the time of commencement of procedural sedation , the treating clinician will give 0.1ml/kg of the prepared solution to a maximum of 10mls.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Group comparisons using Chi square
Continuous varialbels using T Test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299401 0
Hospital
Name [1] 299401 0
Central Coast Local Health District
Address [1] 299401 0
Central Coast Local Health District
Gosford Hospital
Holden Street
Gosford
NSW 2250
Country [1] 299401 0
Australia
Primary sponsor type
Hospital
Name
Central Coast Local Health District
Address
Central Coast Local Health District
Gosford Hospital
Holden Street
Gosford
NSW 2250
Country
Australia
Secondary sponsor category [1] 304314 0
None
Name [1] 304314 0
none
Address [1] 304314 0
Country [1] 304314 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300304 0
Hunter New England Human Research and Ehtics Committee
Ethics committee address [1] 300304 0
Research Ethics and Governance Office
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 300304 0
Australia
Date submitted for ethics approval [1] 300304 0
29/11/2019
Approval date [1] 300304 0
Ethics approval number [1] 300304 0

Summary
Brief summary
This study aims to evaluate the need for Intravenous Fentanyl to provide Procedural analgesia during Direct Current Cardioversion for the treatment of acute onset Atrial fibrillation.
Patents will be randomised to receive a pain relief medication (Fentanyl) or a placebo (Salt water) at the commencement of the procedure. All other elements of the procedure are the same. when the patient emerges and can state their name, the clinician will ask the patient to rank their perception of pain. This will be repeated at 10 minutes from the time the patient was able to state their name. The two groups will be compared to see if the patients receiving the Fentanyl rated their pain differently , to those that did not receive pain relief.
This study aims to redefine and change clinical practice, avoid use of treatments when they are not indicated, improve patient safety by reducing harm from unnecessary treatments or interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83222 0
Dr Shashi Kalava
Address 83222 0
Shashi Kalava Staff Specialist Emergency Physician, Emergency Department, Central Coast Local Health District.
Gosford Hospital
Holden Street
Gosford NSW 2250
Country 83222 0
Australia
Phone 83222 0
+61 243202111
Fax 83222 0
Email 83222 0
Shashi.Kalava@health.nsw.gov.au
Contact person for public queries
Name 83223 0
Dr Shashi Kalava
Address 83223 0
Shashi Kalava Staff Specialist Emergency Physician, Emergency Department, Central Coast Local Health District.
Gosford Hospital
Holden Street
Gosford NSW 2250
Country 83223 0
Australia
Phone 83223 0
+61 243202111
Fax 83223 0
Email 83223 0
Shashi.Kalava@health.nsw.gov.au
Contact person for scientific queries
Name 83224 0
Dr Christopher Trethewy
Address 83224 0
Christopher Trethewy Senior Staff Specialist Emergency Physician,
Director of Research emergency Departments Central Coast Local Health District,
Gosford Hospital
Holden Street
Gosford NSW 2250
Country 83224 0
Australia
Phone 83224 0
+61 243203648
Fax 83224 0
Email 83224 0
christopher.trethewy@health.nsw.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
No individula participant data will be shared beyond the immediate reserach group.
What supporting documents are/will be available?
No other documents available
Summary results
No Results