Trial Outcomes & Findings for Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes (NCT NCT02409810)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

5 days

Results posted on

2023-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCA-DEX Patients n=20 Participants 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. 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.
Age, Continuous	45.1 years n=20 Participants
Sex: Female, Male Female	9 Participants n=20 Participants
Sex: Female, Male Male	11 Participants n=20 Participants
Region of Enrollment United States	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 5 days

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.

Outcome measures

Outcome measures
Measure	PCA-DEX Patients n=20 Participants 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. 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.
Number of Participants Successfully Completing the Pilot Trial Without Adverse Effects	16 Participants

PRIMARY outcome

Timeframe: 5 days

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

Outcome measures

Outcome measures
Measure	PCA-DEX Patients n=20 Participants 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. 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.
Feasibility Outcome #1 Number of Patients Who Consent to Enrollment	20 Participants

PRIMARY outcome

Timeframe: 5 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

Outcome measures

Outcome measures
Measure	PCA-DEX Patients n=20 Participants 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. 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.
Feasibility Outcome #2 - Number of Patients Adhering to Protocol Over the Total Number of Eligible Intervention Days	20 participants

SECONDARY outcome

Timeframe: 5 days

Patients evaluation of PCS-DEX in regards to their willingness to use PCA-DEX prior to and during burn dressing changes to self-manage anxiety and their satisfaction ratings with anxiety self-management.

Outcome measures

Outcome measures
Measure	PCA-DEX Patients n=20 Participants 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. 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.
Patient Acceptability (Number of Patients Willing to Use PCS-DEX Prior to and During Burn Dressing Changes)	20 Participants

Adverse Events

PCA-DEX Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judy Opalek Director, Research Administration

The Ohio State University

Phone: 6147789696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place