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NCT02409810 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Anxiety and Burns, sponsored by Ohio State University.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT02409810: Completed Phase 1 study of Anxiety and Burns, sponsored by Ohio State University.

NCT02409810 is a Phase 1 study of Anxiety and Burns that has completed, run by Ohio State University. The registered enrollment target is 20 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02409810, a Phase 1 study of Anxiety and Burns, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study 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 sel

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Dexmedetomidine

Study Locations (1)

Ohio

  • The Ohio State University Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-04
Est. Completion 2020-03-20
Phase Phase 1
Ohio State University

552 total trials

What the finished NCT02409810 record still lists

NCT02409810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Dexmedetomidine is the first listed.

NCT02409810 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT02409810 about?

NCT02409810 is a clinical study titled "Patient-Controlled Anxiolysis With Dexmedetomidine (PCA-DEX) for Burn-care Dressing Changes". 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 sympt...

What is the current status of trial NCT02409810?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-04. Estimated completion is 2020-03-20.

What conditions does trial NCT02409810 study?

This clinical trial studies the following conditions: Anxiety, Burns.

What interventions are being tested in trial NCT02409810?

The interventions under investigation include: Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT02409810?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02409810 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Anxiety

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02409810's enrollment target sits among peer trials

20 326th of 364 higher than 34 of 364 other Anxiety trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02409810, the US trial registry maintained by the National Library of Medicine. NCT02409810 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.