The DAFF Study – Direct Current Cardioversion for acute onset Atrial Fibrillation in the Emergency department and the need for Fentanyl.

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)

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001647123

Acronym

DAFF Study – Direct Current Cardioversion, Atrial Fibrillation and Fentanyl use

Enrollment

128

Registered

2019-11-26

Start date

2020-12-02

Completion date

2023-08-04

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 sali

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

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

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

Outcome results