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Ketamine Sickle Cell Disease (SCD)

Primary Purpose

SC Disease, Pain, Chronic

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Ketamine

About this trial

This is an interventional treatment trial for SC Disease focused on measuring Ketamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects diagnosed with sickle cell anemia
Adults aged 18 and older
Subjects who have given written consent

Exclusion Criteria:

Subjects who are pregnant
Subjects younger than 18 years
Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications
Subjects who have a contraindication to ketamine

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ketamine

Opioid Only

Arm Description

Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg

Patient-controlled analgesia Dilaudid 2.0-2.5 mg

Outcomes

Primary Outcome Measures

Total opioid Use in milligrams morphine equivalents

Pain scores measured on the Visual Analog Scale 0 - 10

Secondary Outcome Measures

Cost of pharmacotherapy

monetary cost of intervention used

Length of hospital stay

Length of stay in the hospital

Nausea and vomiting scores Visual Analog Scale 0 - 10

Full Information

NCT ID

NCT03502421

First Posted

April 10, 2018

Last Updated

September 24, 2018

Sponsor

University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT03502421

Brief Title

Ketamine Sickle Cell Disease

Acronym

SCD

Official Title

A Randomized Controlled Trial to Determine the Efficacy of Ketamine as an Adjunct for Pain Management in Patients With Sickle Cell Crisis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Never IRB approved, no intention to proceed with the study

Study Start Date

September 1, 2018 (Anticipated)

Primary Completion Date

September 1, 2019 (Anticipated)

Study Completion Date

November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction of blood vessels resulting in ischemic injury and pain. The pain experienced during these episodes is due to a wide range of pathophysiological processes. Though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the predominate treatment for VOC. However, the efficacy of these treatments has come into question. A large sub-set of patients with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment modalities. New classes of drugs are being tested to prevent and treat acute pain associated with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap. The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal models and clinical settings. Ketamine utilized as a low dose continuous infusion could benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. Further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with SCD-related pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SC Disease, Pain, Chronic

Keywords

Ketamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Prospective Clinical Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine

Arm Type

Experimental

Arm Description

Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg

Arm Title

Opioid Only

Arm Type

No Intervention

Arm Description

Patient-controlled analgesia Dilaudid 2.0-2.5 mg

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour

Primary Outcome Measure Information:

Title

Total opioid Use in milligrams morphine equivalents

Description

Total opioid Use in milligrams morphine equivalents

Time Frame

1-3 hours

Title

Pain scores measured on the Visual Analog Scale 0 - 10

Description

Pain scores measured on the Visual Analog Scale 0 - 10

Time Frame

1-3 hours

Secondary Outcome Measure Information:

Title

Cost of pharmacotherapy

Description

monetary cost of intervention used

Time Frame

1 day

Title

Length of hospital stay

Description

Length of stay in the hospital

Time Frame

1-7 days

Title

Nausea and vomiting scores Visual Analog Scale 0 - 10

Description

Nausea and vomiting scores Visual Analog Scale 0 - 10

Time Frame

1-3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects diagnosed with sickle cell anemia Adults aged 18 and older Subjects who have given written consent Exclusion Criteria: Subjects who are pregnant Subjects younger than 18 years Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications Subjects who have a contraindication to ketamine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enrico Camporesi, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28853040

Citation

Puri L, Nottage KA, Hankins JS, Anghelescu DL. State of the Art Management of Acute Vaso-occlusive Pain in Sickle Cell Disease. Paediatr Drugs. 2018 Feb;20(1):29-42. doi: 10.1007/s40272-017-0263-z.

Results Reference

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PubMed Identifier

23565738

Citation

Neri CM, Pestieau SR, Darbari DS. Low-dose ketamine as a potential adjuvant therapy for painful vaso-occlusive crises in sickle cell disease. Paediatr Anaesth. 2013 Aug;23(8):684-9. doi: 10.1111/pan.12172. Epub 2013 Apr 9.

Results Reference

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PubMed Identifier

16854557

Citation

Visser E, Schug SA. The role of ketamine in pain management. Biomed Pharmacother. 2006 Aug;60(7):341-8. doi: 10.1016/j.biopha.2006.06.021. Epub 2006 Jul 5.

Results Reference

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PubMed Identifier

21778336

Citation

Aguado D, Abreu M, Benito J, Garcia-Fernandez J, Gomez de Segura IA. Ketamine and remifentanil interactions on the sevoflurane minimum alveolar concentration and acute opioid tolerance in the rat. Anesth Analg. 2011 Sep;113(3):505-12. doi: 10.1213/ANE.0b013e318227517a. Epub 2011 Jul 21.

Results Reference

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PubMed Identifier

27599837

Citation

Sun J, Lin H, Feng X, Dong J, Ansong E, Xu X. A comparison of intrathecal magnesium and ketamine in attenuating remifentanil-induced hyperalgesia in rats. BMC Anesthesiol. 2016 Sep 6;16(1):74. doi: 10.1186/s12871-016-0235-9.

Results Reference

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Ketamine Sickle Cell Disease

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