A Randomized, Double-Blind Study of Placebo vs. Ketamine For Use During Dressing Changes in Critically Ill Burn Patients
Status:
Withdrawn
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
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.