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

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Patients age 18- 89 admitted for initial management of a thermal burn injury (flame, scald, contact) with >1% total body surface area

• Expected stay on the Burn Center for 3 or more days

• Read, write and speak English

• Burn injury experienced <48 hours prior to admission to the Burn Center for care

Exclusion Criteria:

• Patients who are pregnant

• Patients that are incarcerated

• Patients in active alcohol withdrawal

• Patients with current hemodynamic instability (current hypotension systolic blood pressure <100 mmHg, sustained heart rate < 60 beats/min without a pacemaker, symptomatic bradycardia, or second or third degree heart block)

• Cannot use push button PCA device (i.e., paralysis)

• Acute hepatitis

• Acute liver failure

• Acute stroke

• Acute seizures

• Acute myocardial infarction

• Severe cognition or communication difficulties (e.g., coma, deafness without signing literacy, dementia, non-English speaking)

• Chemical or electrical burn injury

• Any condition precluding inclusion at the discretion of the burn surgeons