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

NCT ID: NCT02801292

Last Updated: 2016-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-07-31

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.

Conditions

Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

administering of ketamine

adjuvant to standard of care

Group Type: OTHER

Ketamine

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Other Intervention Names

ketamine hydrochloride

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Central Contacts

George Hsu, MD

Role: CONTACT

ghsu@augusta.edu

404-556-7250

Natalie Lane, MD

Role: CONTACT

nlane@augusta.edu

706-721-4467

References

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.

Reference Type: BACKGROUND

PMID: 1710777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12826855 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8657426 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10551055 (View on PubMed)

Other Identifiers

917282

Identifier Type: -

Identifier Source: org_study_id