Acute PainPhase 4NCT03305055
RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
A Phase 4 study testing ketamine and Fentanyl in people with Acute Pain and Wound Care, run by Johns Hopkins University at 1 site in United States.
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". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain, Wound Care, Posttraumatic Stress Disorder
- What is being tested?
- ketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2017to 21 Apr 2018
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Burn Center
Baltimore, Maryland, 21224
About this study
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.
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).
Read the detailed 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:
- 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.
- 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:
- 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,
- 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.
- Conditions
- Acute Pain, Wound Care, Posttraumatic Stress Disorder
- Keywords
- opioid, ketamine
- Medical subject headings
- Acute Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Also called STUDY DRUG GROUP (Fentanyl plus Ketamine)
Information included in arm descriptions
FentanylDrug
Also called USUAL CARE GROUP (Fentanyl plus saline/placebo)
Information included in arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl Plus Ketamine | Experimental | Study drug group
1. Ketamine Loading Dose (Low Dose, Slow Infusion) =
• 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, … Then,
2. Fentanyl Loading Dose (UC, injection) =
• 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated < 1 minute prior to wound care.
3. Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.
Fentanyl PRN dose* = 1 mcg / kg. Provided when participant requires additional pain medication. Receives: Drug: ketamine; Drug: Fentanyl |
| Fentanyl Plus Saline | Active comparator | Usual care group
1. Saline Loading Dose (Low Dose, Slow Infusion) =
• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...
2. Fentanyl Loading Dose (UC, injection) =
• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.
3. Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.
FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Wound Care Pain
Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.
Measured: Up to 40 days
Trajectory of Mean Wound Care Session Pain Within Sessions
Trajectory of average pain within session
Measured: 7-days, within session
Trajectory of Mean Wound Care Session Pain Across Sessions
Trajectory of average pain across 7 day study protocol
Measured: 7-Days across sessions
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).
Measured: 37 days
Secondary outcomes (2)
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.
Measured: 37 days
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.
Measured: 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start16 Dec 2017
- Primary completion28 Mar 2018
- Study completion21 Apr 2018
Why it stopped: Funding withdrawn - slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, repeated exposure (twice daily, 7 days), safety and efficacy trial of Usual Care (fentanyl PLUS saline / placebo) versus Usual Care plus Study Drug Augmentation (fentanyl PLUS ketamine) in reducing acute pain severity assessed before, during and after wound care for acute burn injury in the Burn Center of an Academic Medical Center.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- James A Fauerbach, PhD, Principal investigator, Johns Hopkins University SOMKevin Gerold, DOJD, Principal investigator, Johns Hopkins University SOMJulie Caffrey, DO, Study director, Johns Hopkins University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305055
- Sponsor's protocol ID
- IRB00089761
- Other IDs
- NTI-NTRR15-13
- Status last verified
- Feb 2019
- First submitted
- 12 Jun 2017
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan not operationalized as yet.