RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/14/2019 |
| Start Date: | December 16, 2017 |
| End Date: | April 21, 2018 |
Evaluating the Safety, Efficacy and Opiate Sparing Effects of Low-Dose, Slow Infusion Ketamine as a Battlefield Analgesic for Acute Pain in Burn Wounds.
The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group
trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine
Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of
Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual
Care-Opiate (UC-O), dose/timing as per Burn Center protocol).
trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine
Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of
Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual
Care-Opiate (UC-O), dose/timing as per Burn Center protocol).
Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC)
are funding this RCT for the following reasons:
Primary Aims:
1. To evaluate the safety and efficacy of fentanyl (usual care) + placebo versus fentanyl +
ketamine (low-dose, sub-anesthetic, slow-infusion) during twice daily burn wound care
across a 7-day study period and 30 day outcome period.
2. To evaluate the opiate sparing effect of fentanyl (usual care) + placebo versus fentanyl
+ ketamine (low-dose, sub-anesthetic, slow-infusion) during the 7-day study period and
30 day outcome period.
and
Secondary Aims:
1. To determine the short and long term effect of the Ketamine Augmentation Condition
versus the Usual Care Condition on symptoms and syndromes of posttraumatic stress
disorder and of depression,
2. To evaluate several established and hypothesized moderators of the relationship between
the Ketamine Augmentation Condition versus the Usual Care Condition on: 1) pain severity
reported during wound care, 2) opiate use during wound care, 3) posttraumatic stress and
4) depression.
are funding this RCT for the following reasons:
Primary Aims:
1. To evaluate the safety and efficacy of fentanyl (usual care) + placebo versus fentanyl +
ketamine (low-dose, sub-anesthetic, slow-infusion) during twice daily burn wound care
across a 7-day study period and 30 day outcome period.
2. To evaluate the opiate sparing effect of fentanyl (usual care) + placebo versus fentanyl
+ ketamine (low-dose, sub-anesthetic, slow-infusion) during the 7-day study period and
30 day outcome period.
and
Secondary Aims:
1. To determine the short and long term effect of the Ketamine Augmentation Condition
versus the Usual Care Condition on symptoms and syndromes of posttraumatic stress
disorder and of depression,
2. To evaluate several established and hypothesized moderators of the relationship between
the Ketamine Augmentation Condition versus the Usual Care Condition on: 1) pain severity
reported during wound care, 2) opiate use during wound care, 3) posttraumatic stress and
4) depression.
Inclusion Criteria:
- Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40%
TBSA
- English speaking
- pain in emergency room during initial wound evaluation (on admission) greater than 5
/10
- estimated length of stay greater than or equal to 5 days
Exclusion Criteria:
- requiring endotracheal intubation and sedation,
- severe hearing impairment,
- cognitive impairment status - Mini-Mental State Examination (MMSE)
- diminished capacity unable to provide informed consent;
- Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
- Safety: contraindication (e.g., potential drug interactions or medical comorbidities)
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