Ketamine Infusion for Sickle Cell Pain Crisis

NCT04005209 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00100887
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Sickle-Cell, With Crisis; Acute Pain

Keywords

Ketamine; Intravenous Infusions; Anemia; Sickle-Cell, with Crisis; Acute Pain

Outcome Measures

Primary Outcomes (1)

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

  baseline, 72 hours

Secondary Outcomes (3)

• Percentage reduction in grand mean pain score using the 11-point visual analog scale

  baseline, 72 hours

• 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

Study Arms (2)

Pain management without ketamine infusion

ACTIVE COMPARATOR

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

Other: Pain management

Pain management with ketamine infusion

EXPERIMENTAL

Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.

Drug: Ketamine; Other: Pain management

Interventions

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 with ketamine infusion

Pain management OTHER

Pain management

Pain management with ketamine infusion; Pain management without ketamine infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Vaso-Occlusive Crises; Acute Pain

Interventions

Ketamine; Pain Management

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: January 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)