Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes

Summary

The primary aim of this pilot study is to establish the safety and feasibility of patient-controlled administration with dexmedetomidine for anxiolysis (PCA-DEX) during burn care dressings for patients with burn injury. The secondary aim is to determine the acceptability of PCA-DEX for anxiety symptom management by patients with burn injury and nursing staff caring for these patients. Objectives Primary Aim #1 Safety: To examine the safety of PCA-DEX as determined by the proportion of patients successfully completing the pilot trial without adverse effect which include significant hypotension, bradycardia, or agitation from uncontrolled anxiety. Primary Aim #2 Feasibility: The primary objective of this study is to establish feasibility of subject recruitment and protocol adherence in a pilot study of PCA-DEX in patients with burn injury requiring dressing changes. Feasibility will be defined by the following criteria: a) number and proportion of patients who consent to enrollment, b) proportion of eligible subjects enrolled prior to first dressing change, c) number of days on protocol that patients successfully use the PCS device, d) ability of burn nurses to adjust the pump and adhere to the infusion rates of the PCA-DEX protocol. Secondary Aim #1 Patient Acceptability: A secondary objective of this pilot study is to have patients evaluate PCA-DEX in regards to patients' willingness to use PCA-DEX prior to and during burn dressing changes to self-manage anxiety and their satisfaction ratings with anxiety self-management. Secondary Aim #2 Nurse Acceptability: Another secondary aim of this pilot study is to evaluate the nursing staffs' acceptability of the PCA-DEX protocol for patients' to self-manage anxiety surrounding burn care dressing changes. Hypotheses #1: PCA-DEX protocol will be safe to administer during burn care dressing changes. #2: PCA-DEX will be feasible to implement on the Burn Center at OSUWMC. #3: Patients will favorably appraise PCA-DEX for the self-control of anxiety associated with burn care dressing changes, and be satisfied with PCA-DEX for the management of anxiety. #4: Nursing Staff will favorably appraise PCA-DEX while performing burn care dressing changes.

Conditions

• Anxiety
• Burns

Interventions

DRUG

Dexmedetomidine

Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10 minutes by nursing staff, followed by a continuous infusion of Precedex® at 0.4 mcg/kg/hr via a standard infusion pump (LifeCare PCA). Patients will self-medicate as needed for anxiety self-management by self-administering a bolus of Precedex® 0.1 mcg/kg. This dosage is within the FDA-approved package insert parameters. Heart rate, blood pressure and oxygen saturation will be closely monitored by a staff RN already trained to provide care in the procedure room. 1 hour prior to- and after completion of the burn dressing change each day using a 100-mm visual analog scale. Patients will both rate their satisfaction with PCA-DEX for anxiety management after each completion of the burn dressing change.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Larry Jones, MD · Ohio State University

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2020-03-20

Completion

2020-03-20

FDA Drug

Yes

Countries

• United States

Study Locations