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Trial record 32 of 26546 for:    Change | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02409810
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Ohio State University

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.

Condition or disease Intervention/treatment Phase
Anxiety Burns Drug: Dexmedetomidine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety, Feasibility, and Acceptability of Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes
Study Start Date : March 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Burns

Arm Intervention/treatment
Experimental: PCA-DEX Patients
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
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.
Other Name: Precedex, PCS-DEX




Primary Outcome Measures :
  1. Safety (proportion of patients successfully completing the pilot trial without adverse effects) [ Time Frame: 5 days ]
    To examine the safety of PCA-DEX as determined by the proportion of patients successfully completing the pilot trial without adverse effects.

  2. Feasibility (defined by the following criteria: a) number and proportion of patients who consent to enrollment, b) proportion of eligible subjects c) number of days on protocol that patients successfully use the PCS device, d) ability of burn nurses) [ Time Frame: 1 year ]
    Establish feasibility of subject recruitment and protocol adherence in a pilot study of PCS-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 PCS-DEX protocol.


Secondary Outcome Measures :
  1. Patient Acceptability (willingness to use PCS-DEX prior to and during burn dressing changes) [ Time Frame: 5 days ]
    Patients evaluation of PCS-DEX in regards to their willingness to use PCS-DEX prior to and during burn dressing changes to self-manage anxiety and their satisfaction ratings with anxiety self-management.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409810


Contacts
Contact: Larry Jones, MD 614-293-5710 jones.4101@osu.edu
Contact: Linda Chlan, PhD, RN 614-292-8341 chlan.1@osu.edu

Locations
United States, Ohio
The Ohio State University Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Larry Jones, MD    614-293-5710    jones.4101@osu.edu   
Contact: Linda Chlan, PhD, RN    614-292-8341    chlan.1@osu.edu   
Sponsors and Collaborators
Ohio State University

Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT02409810     History of Changes
Other Study ID Numbers: 2015H0019
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action