Anemia; Sickle-Cell, With CrisisPhase 4NCT04005209
Ketamine Infusion for Sickle Cell Pain Crisis
A Phase 4 study testing Ketamine and Pain management in people with Anemia; Sickle-Cell, With Crisis and Acute Pain, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anemia; Sickle-Cell, With Crisis, Acute Pain
- What is being tested?
- Ketamine and Pain management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation
- Admitted to Duke University Hospital with a clinical diagnosis of sickle cell crisis
- Are at least 18 years old at time of admission
- Have been admitted to any hospital for sickle cell pain crisis at least twice in the last year
- Have documented severe pain at time of admission, requiring intravenous opiates
- Must be able to speak English
Who cannot join
- Are greater than 70 years old at time of admission
- Carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis
- Are pregnant or breastfeeding
- Are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis
- Have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year
- Were admitted to any hospital for sickle cell pain crisis within the last 30 days
- Are able to fully and properly consent for their own medical care, with no restrictions or limitations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.
The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient population.
- Conditions
- Anemia; Sickle-Cell, With Crisis, Acute Pain
- Being tested
- Ketamine, Pain management
- Keywords
- Ketamine, Intravenous Infusions, Anemia; Sickle-Cell, with Crisis, Acute Pain
- Medical subject headings
- Vaso-Occlusive Crises, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
The experimental group will receive a ketamine intravenous infusion, initiated at 0.2 mg/kg/hr within the first 12 to 24 hours on an inpatient admission for sickle cell pain crisis, and titrated per hospital policy by the inpatient pain service.
Pain managementOther
Pain management
| Study group | Role | What they receive |
|---|---|---|
| Pain management without ketamine infusion | Active comparator | Pain management without ketamine infusion. No other restrictions on pain management or medications. Receives: Other: Pain management |
| Pain management with ketamine infusion | Experimental | Pain management that includes a ketamine infusion. No other restrictions on pain management or medications. Receives: Drug: Ketamine; Other: Pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in grand mean opioid consumption from 0 to 72 hours
Measured: baseline, 72 hours
Secondary outcomes (3)
Percentage reduction in grand mean pain score using the 11-point visual analog scale
Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
Measured: baseline, 72 hours
Time from inpatient admission to readiness for discharge
Measured: Upon discharge from the hospital (an average of 1 week)
30-day hospital readmission rate
Measured: 30 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study startJan 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Decided not to open study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia; Sickle-Cell, With CrisisStudies of the same condition, open and under way.
- More trials run by Duke 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005209
- Sponsor's protocol ID
- Pro00100887
- Status last verified
- Dec 2021
- First submitted
- 28 Jun 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Low-dose Ketamine Infusion Versus Usual Care for Sickle Cell Pain Crisis: a Randomized, Prospective Study.
- ClinicalTrials.gov ID
- NCT04005209
- Acronym / sponsor ID
- Pro00100887
- Conditions
- Anemia; Sickle-Cell, With Crisis, Acute Pain
- Keywords
- Ketamine, Intravenous Infusions, Anemia; Sickle-Cell, with Crisis, Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided not to open study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain management without ketamine infusion | Active comparator | Other: Pain managementPain management without ketamine infusion. No other restrictions on pain management or medications. |
| Pain management with ketamine infusion | Experimental | Drug: Ketamine, Other: Pain managementPain management that includes a ketamine infusion. No other restrictions on pain management or medications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation
- Admitted to Duke University Hospital with a clinical diagnosis of sickle cell crisis
- Are at least 18 years old at time of admission
- Have been admitted to any hospital for sickle cell pain crisis at least twice in the last year
- Have documented severe pain at time of admission, requiring intravenous opiates
Key exclusion criteria (7 listed)
- Are greater than 70 years old at time of admission
- Carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis
- Are pregnant or breastfeeding
- Are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis
- Have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineThe experimental group will receive a ketamine intravenous infusion, initiated at 0.2 mg/kg/hr within the first 12 to 24 hours on an inpatient admission for sickle cell pain crisis, and titrated per hospital policy by the inpatient pain service. | Drug | Pain management with ketamine infusion |
| Pain managementPain management | Other | Pain management with ketamine infusion, Pain management without ketamine infusion |
Primary outcome
Percentage reduction in grand mean opioid consumption from 0 to 72 hours
Time frame: baseline, 72 hours
3 secondary outcomes
Percentage reduction in grand mean pain score using the 11-point visual analog scale
Time frame: baseline, 72 hours
Time from inpatient admission to readiness for discharge
Time frame: Upon discharge from the hospital (an average of 1 week)
30-day hospital readmission rate
Time frame: 30 days from discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Pain management in people with Anemia; Sickle-Cell, With Crisis and Acute Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in grand mean opioid consumption from 0 to 72 hours (time frame: baseline, 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.