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

NCT02409810 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2015H0019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Number of Participants Successfully Completing the Pilot Trial Without Adverse Effects

  Post-PCA-DEX Acceptability Survey was completed to measure the Patient acceptability. Upon completion of the PCA-DEX protocol, subjects were asked about their satisfaction with self-administration of medication to manage anxiety, ease of medication administration, and the resulting level of relaxation by completing the PCA-DEX acceptability survey.

  5 days

• Feasibility Outcome #1 Number of Patients Who Consent to Enrollment

  Total patients who consented to enrollment among those in eligible patient population

  5 days

• Feasibility Outcome #2 - Number of Patients Adhering to Protocol Over the Total Number of Eligible Intervention Days

  To establish feasibility by evaluating protocol adherence as defined by the total number of intervention days without protocol violation (defined as non-compliance with intervention implementation, infusion rates and/or pump adjustment) over the total number of eligible intervention days

  5 days

Secondary Outcomes (1)

• Patient Acceptability (Number of Patients Willing to Use PCS-DEX Prior to and During Burn Dressing Changes)

  5 days

Study Arms (1)

PCA-DEX Patients

EXPERIMENTAL

Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10mins by nurse 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.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex, PCS-DEX

PCA-DEX Patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Hospital

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Burns

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Judy Opalek Director, Research Administration
• Organization: The Ohio State University

judy.opalek@osumc.edu

6147789696

Study Officials

• Larry Jones, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 7, 2015
• Study Start: April 1, 2015
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)