Ketamine Infusion for Sickle Cell Pain Crisis

Phase 4

Withdrawn

• Conditions: Anemia; Sickle-Cell, With Crisis; Acute Pain
• Interventions: Other: Pain management; Drug: Ketamine

• Registration Number: NCT04005209
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Study Start: 2022-01
• Last Update Posted: 2022-01-14
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain management without ketamine infusion	Pain management	Pain management without ketamine infusion. No other restrictions on pain management or medications.
Pain management with ketamine infusion	Ketamine	Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.
Pain management with ketamine infusion	Pain management	Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time from inpatient admission to readiness for discharge	Upon discharge from the hospital (an average of 1 week)
Percentage reduction in grand mean pain score using the 11-point visual analog scale	baseline, 72 hours	Using standard 11-point visual analog pain scale, ranging from 0 = no pain to 10 = worst pain imaginable.
30-day hospital readmission rate	30 days from discharge

Trial Locations

Locations (1)

Duke Hospital; 🇺🇸 Durham, North Carolina, United States