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

Phase

Condition

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT02801292

917282

Ages 3-17
All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Pediatric patients (> 3 yrs and <18yrs) with a previous diagnosis of sickle celldisease (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

Exclusion Criteria:

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% frompatient's baseline
Unstable Vital Signs
Patients who have received intravenous pain medicine within 24 hours of visit tothe 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 regimenper protocol.

Study Design

July 01, 2016

July 31, 2018

Study 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.