Ketamine Infusion for Sickle Cell Pain Crisis

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Pain; Anemia; Sickle-Cell, With Crisis
• Intervention / Treatment: Other: Pain management; Drug: Ketamine

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pain management without ketamine infusion; Pain management without ketamine infusion. No other restrictions on pain management or medications.	Other: Pain management; Pain management
Experimental: Pain management with ketamine infusion; Pain management that includes a ketamine infusion. No other restrictions on pain management or medications.	Other: Pain management; Pain management; Drug: Ketamine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage reduction in grand mean opioid consumption from 0 to 72 hours	baseline, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Ketamine; Acute Pain; Intravenous Infusions; Anemia; Sickle-Cell, with Crisis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Acute Pain; Anemia, Sickle Cell; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Pro00100887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes