Dental Anesthesia in Heart Failure Patients (DAHFP)

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: Lidocaine with epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02228083

InsufCard

Details and patient eligibility

About

To investigate the occurrence of arrhythmias in dental treatment with local anesthetic.

Full description

Heart failure is defined as the inability of the heart to offer blood supply required to meet metabolic demand of the tissues and thus exercise adequately its role as a pump. According to data collected from the single health system (DATASUS), approximately 6.4 million Brazilians have heart failure. This large contingent of patients will require multi-professional treatment, in particular, careful with dental health heart failure is regarded as the final common pathway of most cardiovascular diseases and, after installation of symptoms (mainly in the stages of functional class NYHA III and IV) have poor prognosis with average survival of 1.7 years 3.2 years for men and for women. Dental treatment often requires application of local anesthetic. The adrenaline, agent vasoconstrictor, is widely used in dental treatment and aims to extend the effect of local anesthetic. Specifically in people with heart failure, there shortcomings of evidence in the literature, the harmful effects of adrenaline 1:100,000 added to the local anaesthetic lidocaine. Among the potential complications, we can highlight: arrhythmias, systemic blood pressure elevation and elevation of heart rate. The main objective of this work will investigate the occurrence of arrhythmias by evaluating of electrocardiographic parameters. Our secondary objectives will be assessing: variations of blood pressure by ambulatory blood pressure monitoring, cardiac frequency and chest pain. We will study 70 patients between 18 and 75 years with a diagnosis of congestive heart failure functional class NYHA III and IV and restorative dental treatment indication. A random picture in double-blind study, patients are divided into two groups, one group receives as local anesthetic lidocaine 2% with adrenaline 1 in comparison with the second group that will receive 2% lidocaine with vasoconstrictor.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any race,nationality,profession, single or married.
• class II , III or IV of New York heart Association ( NYHA)
• minimum 45% ventricular ejection fraction
• patient must be in a clinical treatment or hospital treatment
• patient must need dental restorative treatment , mandible or maxilla, due to caries or need for substitution of a inadequate dental filling.

Exclusion criteria

• patients with history of heart attack within less than three months
• acute myocardial infarction
• unstable angina
• significant ventricular dysfunction
• severe ventricular arrhythmia
• malignant hypertension
• neoplasms
• sepsis
• pregnancy
• allergy to lidocaine and epinephrine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Safety of dental anesthesia

Active Comparator group

Description:

Application of local dental anesthesia with two cartridges (5,6 mL) of the lidocaine 2% with epinephrine 1:100.000 in heart failure patients in functional class III or IV.

Treatment:

Drug: Lidocaine with epinephrine

Oral health profile

Other group

Description:

An oral health profile of patients with heart failure will be described based in oral clinical examination.

Treatment:

Drug: Lidocaine with epinephrine