Ketamine Infusion for Sickle Cell Pain Crisis

Ketamine

Brief 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. 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.

Intervention / Treatment

Ketamine (DRUG)

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 management (OTHER)

Condition or Disease

Anemia; Sickle-Cell, With Crisis
Acute Pain

Phase

Phase 4

Study Design

Study type:	INTERVENTIONAL
Status:	Withdrawn
Study results:	No Results Available
Age:	18 Years to 70 Years
Enrollment:	0 (ACTUAL)
Funded by:	Other
Allocation:	Randomized
Primary Purpose:	Treatment
Masking

Clinical Trial Dates

Start date:	Jan 01, 2022	ESTIMATED
Primary Completion:	Nov 01, 2022	ESTIMATED
Completion Date:	Nov 01, 2022	ESTIMATED
Study First Posted:	Jul 02, 2019	ACTUAL
Results First Posted:	Aug 31, 2020
Last Updated:	Dec 29, 2021

Sponsors / Collaborators

Lead Sponsor: Duke University

Lead sponsor is responsible party

Responsible Party: N/A

Location

Durham, North Carolina, USA

Participant Groups

Pain management without ketamine infusion. No other restrictions on pain management or medications.
Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.

Eligibility Criteria

Sex:	All
Minimum Age:	18
Maximum Age:	70
Age Groups:	Adult / Older Adult
Healthy Volunteers:	Yes

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary Outcomes

Percentage reduction in grand mean opioid consumption from 0 to 72 hours baseline, 72 hours

Secondary Outcomes

Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
Time from inpatient admission to readiness for discharge Upon discharge from the hospital (an average of 1 week)
30-day hospital readmission rate 30 days from discharge

More Details

NCT Number:	NCT04005209
Other IDs:	Pro00100887
Study URL:	https://clinicaltrials.gov/study/NCT04005209

Last updated: Sep 29, 2023