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

Phase 3

• Conditions: Sickle Cell Disease
• Interventions: Drug: Ketamine

• Registration Number: NCT02801292
• Lead Sponsor: Augusta University

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 Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Last Update Submitted: 2016-06-10
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15
• Study Start: 2016-07
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
administering of ketamine	Ketamine	adjuvant to standard of care

Primary Outcome Measures

Name	Time	Method
pain score	1 hour	reduction in refractory pain