Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease

NCT02801292 | Unknown Phase 3

• 1 other identifier: 917282
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC).

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• pain score

  reduction in refractory pain

  1 hour

Study Arms (1)

administering of ketamine

OTHER

adjuvant to standard of care

Drug: Ketamine

Interventions

Ketamine DRUG

Single bolus of Ketamine .25 milligrams per kilogram of weight.

Also known as: ketamine hydrochloride

administering of ketamine

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients (\> 3 yrs and \<18yrs) with a previous diagnosis of sickle cell disease (including Hgb S Beta Thalassemia +, Hgb S Alpha Thalassemia, Hgb S HPFH) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis.

You may not qualify if:

• Patients not to have sequelae indicative of complicated disease outside of acute VOC:
• Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
• Aplastic Episode
• Evidence of infection
• Pregnancy or CHF
• Fever (\> 38.4)
• Cholangitis or cholecystitis
• Hypoxia (SaO2 \<90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
• Unstable Vital Signs
• Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
• History of allergic reaction or serious reaction to Ketamine.
• History of significant psychiatric illness
• Patients with no refractory pain after receiving conventional analgesia regimen per protocol.

Sponsors & Collaborators

• Augusta University: lead

Related Publications (4)

• Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.

  PMID: 1710777 BACKGROUND

• Koppert W, Sittl R, Scheuber K, Alsheimer M, Schmelz M, Schuttler J. Differential modulation of remifentanil-induced analgesia and postinfusion hyperalgesia by S-ketamine and clonidine in humans. Anesthesiology. 2003 Jul;99(1):152-9. doi: 10.1097/00000542-200307000-00025.

  PMID: 12826855 BACKGROUND

• Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2.

  PMID: 8657426 BACKGROUND

• Bergman SA. Ketamine: review of its pharmacology and its use in pediatric anesthesia. Anesth Prog. 1999 Winter;46(1):10-20.

  PMID: 10551055 BACKGROUND

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

Study Officials

• George Hsu, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Hsu, MD

CONTACT

404-556-7250; ghsu@augusta.edu

Natalie Lane, MD

CONTACT

706-721-4467; nlane@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 15, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 15, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share