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WithdrawnPhase 4

A Randomized, Double-Blind Study of Placebo vs. Ketamine For Use During Dressing Changes in Critically Ill Burn Patients

NCT02336308 · University of Colorado, Denver

Closed to entry
Status
Not accepting participants
Phase 4
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

Burn-related pain is severe and often difficult to manage. Healthcare workers struggle with keeping burn patients comfortable, especially when these patients undergo dressing changes of their burn wounds of their skin since these procedures often cause severe pain. Patients with burn wounds frequently require high doses of opioids (narcotics) and calming (anxiolytic) agents to the extent that clinicians must weigh the risks associated with these doses against achieving adequate analgesia and comfort. The biggest risk is over-sedation to cause breathing troubles. Inadequate pain control during these procedures heightens pain perception, anxiety, and fear surrounding the experience and may lead to patients experiencing additional psychological disorders like depression, acute stress disorder (ASD), and post-traumatic stress disorder (PTSD). Therefore, therapeutic options for better management of pain and anxiety during these procedures need to be identified. This study will address whether the addition of ketamine during dressing changes improves patients' pain control and comfort and whether this leads to favorable psychological outcomes. The study is designed to compare ketamine with placebo when they are added to usual care (opioids and anxiolytics) during dressing changes. The main outcomes of the study will be the amount of opioid and anxiolytic agents each group receives during their procedure; the presence of pain-related anxiety shortly after the procedures; blood markers of stress during the procedures; and the presence of depression, anxiety and stress disorders prior to discharge. This study will assess whether the early administration of ketamine reduces pain and anxiety to prevent the need for high doses of opioids and anxiolytics. A total of 30 patients will be enrolled.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Opioid and benzodiazepine requirements before, during, and after dressing changes between placebo and ketamine

    Measured over Four hours

  • Pain levels before, during, and after dressing changes between placebo and ketamine.

    Measured over Four hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 89 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. ≥ 5% TBSA 2. Dressing changes planned to be completed in the burn treatment room 3. Approval from the attending physician Exclusion Criteria: 1. Inhalation injury 2. Electrical injury 3. Patients requiring mechanical ventilation during dressing changes 4. Previous diagnosis of PTSD 5. Systolic blood pressure exceeding 180 mmHg within six hours of the planned dressing change unrelated to pain or anxiety 6. Patients \<18 or \>89 years of age 7. Patient pending transfer to another facility 8. Patients with known or suspected severe adverse reactions to ketamine 9. Patients who have already participated (i.e. previously randomized) and are readmitted to an ICU after being discharged from UCH 10. Prisoners 11. Pregnant females or suspected of being pregnant 12. Unable to comprehend informed consent process or denial of informed consent

Where

1 study site

FacilityCityRegionCountry
University of ColoradoAuroraColoradoUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT02336308 on ClinicalTrials.gov →

Last updated in the registry 2015-11-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits