RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain

Posttraumatic Stress Disorder Clinical Trial

Official title:

Evaluating the Safety, Efficacy and Opiate Sparing Effects of Low-Dose, Slow Infusion Ketamine as a Battlefield Analgesic for Acute Pain in Burn Wounds.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03305055
• Other study ID #: IRB00089761
• Secondary ID: NTI-NTRR15-13
• Status: Terminated
• Phase: Phase 4
• Start date: December 16, 2017
• Est. completion date: April 21, 2018

Study information

• Verified date: February 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 21, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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) </=20,

• 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)

Related Conditions & MeSH terms

• Acute Pain
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Wound Care

Intervention

Drug:
• ketamine
Information included in arm descriptions
• Fentanyl
Information included in arm descriptions

Locations

Country	Name	City	State
United States	Johns Hopkins Burn Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Congressionally Directed Medical Research Programs, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Wound Care Pain	Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.	Up to 40 days
Primary	Trajectory of Mean Wound Care Session Pain Within Sessions	Trajectory of average pain within session	7-days, within session
Primary	Trajectory of Mean Wound Care Session Pain Across Sessions	Trajectory of average pain across 7 day study protocol	7-Days across sessions
Primary	Opiate Sparing Effect	Pro Re Nata (PRN) pain management or adjunct expressed in opiate equivalents (e.g., anxiolytic) or premed (e.g., non-protocol medications for pain, anxiety, etc); post-session (1 and 6 hours post session , e.g., pain, anxiolytic, etc).	37 days
Secondary	Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale	PTSD symptoms score as assessed by Davidson Trauma Scale consisting of 17 items (symptoms) with each item measured for severity and frequency. Each item is rated 0 - 4. Overall score ranges from 0 to 136, with higher scores indicating higher frequency and severity.	37 days
Secondary	Depression Symptoms as Assessed by the Patient Health Questionnaire	Severity and trajectory of depression symptoms as assessed by the Patient Health Questionnaire (PHQ) 9. The questionnaire has 9 items with each rated from 0 to 3. Overall scores ranges from 0 to 27 with 1-4 being minimal depression, 5-9 being mild depression, 10-14 being moderate depression, 15-19 being moderately severe depression and 20-27 being severe depression.	37 days