Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes
Condition: Anxiety; Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Study Procedures Dexmedetomidine PCA Protocol: The PCA-DEX dosing algorithm will consist of a
      loading dose (0.25 mcg/kg) given intravenously over 10 minutes, administered 10 minutes prior
      to the start of burn wound care, followed by a continuous basal infusion of 0.4 mcg/kg/hr
      with 6 allowable patient-controlled self-boluses per hour (0.1 mcg/kg) each with a 10-minute
      lock-out. Drs. Larry Jones and J. Kevin Bailey or their designate will write the PCA-DEX
      medication orders. Subjects will receive standard opioid therapy (oral
      oxycodone/acetaminophen 5/325 mg 60 min. prior and IV morphine 4-12 mg or hydromorphone IV
      0.5-1.5 mg 5 to 10 min. prior and buccal fentanyl 400 mcg as needed during burn wound care)
      and can receive bolus supplemental sedative medications (benzodiazepines) as ordered by Drs.
      Jones or Bailey if needed in the judgment of the burn-care nurse. Subjects will be monitored
      closely by research personnel during the first burn wound care session from 1 hour prior to 1
      hour after completion of burn wound care. Every heart rate and blood pressure recordings will
      be abstracted from the medical record from 1 hour prior to through 1 hour after completion of
      the daily burn wound dressing changes for days 1 through 5. Alert adverse events will be
      reported by research personnel or the patient-care nurse to first the attending physician and
      then to the safety monitor.

      Nurse alert parameters to notify the attending physician and independent safety monitor
      include: heart rate (HR) < 55 beats per min sustained for > 10 min; systolic BP < 90 mm Hg or
      >140 mm Hg sustained for >10 minutes; diastolic BP < 50 mm Hg or >90 mm Hg sustained for >10
      minutes, respiratory rate < 10 breaths per minute sustained for >10 minutes or oxygen
      saturation <92% sustained for >10 minutes; or persistent inability to understand rationale
      for triggering the PCA device despite education and demonstration.

      If the study subject has evidence of sustained hemodynamic instability (HR<60 bpm, SBP <90
      mmHg or DBP < 50 mmHg) during the daily pre-procedure assessment, the patient will not be
      eligible to receive study drug on that day. For that day the patient will receive standard of
      care as appropriate instead of the study intervention. The patient will then be reassessed
      prior to the subsequent study days to determine eligibility for study drug up through day 5.

      Data Collection Measures and Procedures Study entry demographic and descriptive data: Data to
      be recorded includes: age, gender, race, ethnicity, admission weight, severity of burn
      injury, burn etiology, total body surface area burned and depth of injury, and all home and
      hospital medications.

      Daily Measures on Protocol. The following will be obtained from enrolled patients each day by
      a member of the research team.

      Overall anxiety and pain. The abbreviated Burn Specific Anxiety and Pain Scale (BSAPS) on day
      1, 1 hour prior to the first burn dressing change.

      Procedural Anxiety. Anxiety, defined as a state marked by apprehension, agitation, increased
      motor activity, arousal, and fearful withdrawal will be obtained from subjects. Patients will
      evaluate current anxiety level 1 hour before and 1 hour after each burn dressing change using
      a 100-mm Visual Analogue scale-anxiety (VAS-A). Subjects will be asked to rate their current
      level of anxiety on the VAS-A in response to, "How anxious are you feeling today?" A
      100-millimeter vertical line will be anchored on each end by statements 'not anxious at all'
      to 'the most anxious I have ever been'. The VAS-A will have a vertical orientation, as it is
      more sensitive and easier for subjects to use, particularly for those with a narrowed visual
      field or when under stress. Subjects will be asked to mark their current anxiety level on the
      vertical line. Scores will be derived by the distance in millimeters from the bottom anchor
      to the mark placed by the subject, yielding interval level data. Reason(s) for not obtaining
      a daily anxiety assessment will be recorded. The proportion of those assessments completed
      and reasons for non-completion will be used to inform strategies to minimize missing data for
      our planned randomized clinical trial.

      Procedural Pain. Patients' will evaluate current pain level 1 hour before and 1 hour after
      each burn dressing change using a 100-mm Visual Analogue Scale-Pain. Patients will be asked
      to rate their current level of pain on the VAS-P in response to "How much pain are you having
      right now?" A 100-millimeter vertical line will be anchored on each end by statements of 'no
      pain at all' to 'the most pain I have ever experienced'. As with the VAS-A, the vertical
      orientation has been chosen due to increased sensitivity and ease of use for
      patients.Subjects will be asked to mark their current pain level on the vertical line. Scores
      will be derived by the distance in millimeters from the bottom anchor to the mark placed by
      the subject, yielding interval level data. Reason(s) for not obtaining the pain assessments
      will be recorded. The proportion of those assessments completed and reasons for
      non-completion will be used to inform strategies to minimize missing data for our planned
      randomized clinical trial.

      Protocol adherence. A checklist will be completed daily to monitor the number of days
      subjects are able to use the PCA device for up to 5 days. A checklist will also be used to
      monitor the ability of the burn-nurses to adhere to the PCA protocol per instructions.

      Daily adverse event monitoring. Research staff will record and report the presence of
      hypotension, bradycardia (known adverse effects of dexmedetomidine), and protocol deviations
      related to drug, pump or both. Heart rate and blood pressure will be abstracted from the
      medical record. Research team staff or burn-nurses caring for PCA-DEX subjects will alert the
      attending physician and the safety monitor for HR < 55 bpm sustained for > 10 min; systolic
      BP < 90 mm Hg or >140 mm Hg sustained for >10 minutes; diastolic BP < 50 mm Hg or >90 mm Hg
      sustained for >10 minutes, respiratory rate < 10 breaths per minute sustained for >10 minutes
      or oxygen saturation <92% sustained for >10 minutes during the period 1 hour prior through 1
      hour after completion of burn wound dressing change on days 1-5 for any necessary
      intervention or protocol withdrawal.

      Post-PCA-DEX Acceptability Survey. Upon completion of the PCA-DEX protocol, we will query
      subjects and nurses about their satisfaction with self-administration of medication to manage
      anxiety, ease of medication administration, and the resulting level of relaxation.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Precedex, PCS-DEX
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care