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Ketamine Clinical Trials

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

To see complete record on clinicaltrials.gov, please visit this link

Id: NCT02336308

Organisation Name: University of Colorado, Denver

Overal Status: Withdrawn

Start Date: January 2015

Last Update: November 26, 2015

Lead Sponsor: University of Colorado, Denver

Brief 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.

• Thermal Hyperalgesia
• Anxiety
• Pain