Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain

NCT00595530 | Terminated Phase 2 Results DMC

• 1 other identifier: 07-101
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent the development of opiate tolerance and facilitate better pain relief with lower opiate doses, allowing for less respiratory depression, less sedation, easier ambulation, less deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot study is to evaluate the safety and feasibility of using a continuous infusion of ketamine, in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a safe and feasible practice for the treatment of sickle cell pain.

Conditions

Sickle Cell Disease

Keywords

ketamine; vasoocclusive pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale

  Determine if there is an apparent improvement in pain control with the ketamine infusion based on the investigator's discretion and comparison to past pain scores. Pain was scored on a scale from 0 to 10. Zero equaled no pain and 10 equaled a lot of pain.

  Baseline then daily while inpatient, up to 72 hours

Secondary Outcomes (1)

• Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine

  Baseline then daily while inpatient, up to 72 hours

Study Arms (1)

Ketamine

EXPERIMENTAL

This group will receive ketamine

Drug: ketamine

Interventions

ketamine DRUG

Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr. Dosing Regimen: * Patients begin the ketamine infusion at 0.05 mg/kg/hr. * 4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if: 1. patient's pain has not improved to an acceptable level 2. side effects remain acceptable * 4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr * 4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour * Maximum dose of ketamine is limited to 300 mg per 24 hrs Patient may receive ketamine up to 72 hrs after initiation.

Also known as: Ketalar

Ketamine

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CCMC: Children ages 7-22 years (inclusive) with documented sickle cell disease
• UCHC: Adults 18 years (inclusive) and above with documented sickle cell disease
• Sudden onset of acute pain consistent with a vasoocclusive episode -Pain requiring hospitalization, placement on pain protocol, and patient- controlled opiates
• Pain score of greater than or equal to 5 out of 10 when ketamine infusion is started
• Cognitive ability to report pain on a 0 to 10 Numerical Rating Scale (NRS)
• At least one prior hospitalization for vasoocclusive pain at CCMC in the previous 24 months
• Parental consent and child assent

You may not qualify if:

• Children hospitalized for a primary diagnosis other than vasoocclusive episode
• Concurrent Acute Chest Syndrome (ACS)
• Hemoglobin \< 5 mg/dL
• Concurrent history of glaucoma or raised intracranial pressure
• Signs or symptoms consistent with stroke
• History of liver or renal dysfunction
• Pregnancy (females age 12 and above must have pregnancy test)
• Simultaneous participation in investigational drug study
• Primary language spoken other than English
• No hospitalizations to CCMC for vasoocclusive pain in the previous 24 months

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Dr. William T. Zempsky
• Organization: Connecticut Children's Medical Center

wzempsk@ConnecticutChildrens.org

860-837-5207

Study Officials

• William T Zempsky, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain Relief Program

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 16, 2008
• Study Start: March 4, 2008
• Primary Completion: February 12, 2010
• Study Completion: February 12, 2010
• Last Updated: August 21, 2019
• Results First Posted: March 30, 2016

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)