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

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.