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

• ClinicalTrials.gov Identifier: NCT02801292
• Recruitment Status: Unknown
• First Posted: June 15, 2016
• Last Update Posted: June 15, 2016
• Sponsor: Augusta University
• Information provided by (Responsible Party): Augusta University

Tracking Information

• First Submitted Date: June 10, 2016
• First Posted Date: June 15, 2016
• Last Update Posted Date: June 15, 2016
• Study Start Date: July 2016
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2016)

pain score [ Time Frame: 1 hour ]

reduction in refractory pain

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease
• Official Title: Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease, a Pilot Study
• 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).
• Detailed Description: 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). Our study design is as follows: Prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. Consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of Ketamine at a set dosage of 0.25 milligrams per kilogram of weight. Participants' perception of pain will then be recorded using standard pain scoring scales (FLACC score). Physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. Observational study group will continue to get standard of care outside of single bolus of Ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sickle Cell Disease

Intervention

Drug: Ketamine

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

Other Name: ketamine hydrochloride

Study Arms

administering of ketamine

adjuvant to standard of care

Intervention: Drug: Ketamine

Publications *

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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 10, 2016): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2018
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients not to have sequelae indicative of complicated disease outside of acute VOC:

  1. Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
  2. Aplastic Episode
  3. Evidence of infection
  4. Pregnancy or CHF
  5. Fever (> 38.4)
  6. Cholangitis or cholecystitis
  7. Hypoxia (SaO2 <90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
  8. Unstable Vital Signs
  9. Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
  10. History of allergic reaction or serious reaction to Ketamine.
  11. History of significant psychiatric illness
  12. Patients with no refractory pain after receiving conventional analgesia regimen per protocol.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02801292
• Other Study ID Numbers: 917282
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: IPD will not be shared

• Current Responsible Party: Augusta University
• Original Responsible Party: Same as current
• Current Study Sponsor: Augusta University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: George Hsu, MD; Augusta University

• PRS Account: Augusta University
• Verification Date: June 2016