Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Conditions
Keywords
Pain dosed ketamine, pediatric sickle cell pain crisis, Ketamine in sickle cell pain, sickle cell pain
Brief summary
The goal of this study is to learn if Ketamine works more efficiently, as compared to Opioids, for Sickle Cell Pain The main questions it aims to answer are: Does Ketamine lower the number of times participants need to be admitted for continued pain control during a Sickle Cell Pain Crisis. Does Ketamine decrease the amount of time it takes to reach adequate pain control/pain score improvement, as compared to Opioids. Patients could have too low or too high blood pressure or sleepiness. Researchers will compare Ketamine to Opioids (Morphine or Dilaudid) to see if Ketamine works to treat pain enough that you do not need to be admitted to the hospital. Participants will: On arrival to the Children's ER for Sickle Cell Pain crisis will get Ketamine, instead of Morphine or Dilaudid, along with the typical Tylenol, Toradol, Lidocaine patch for pain control while in the ER. During this time we will follow your reported pain scale (0-10) to monitor your pain response to the Ketamine, as well as follow rate of hospital admission.
Detailed description
In this study, we will be using Ketamine for pain control during a Sickle Cell Disease pain crisis, along with our current adjuncts (Tylenol, Toradol, Lidocaine patch, or heat packs), in hopes to lower the rate of admission to the hospital for continued pain control. When presenting to the ER for pain crisis the first dose of Ketamine should be given within 30 minutes of arrival to the ER. Prior to giving Ketamine, vitals and current pain scale will be recorded in the chart. The vitals and pain scale will be rechecked every 30 minutes and documented in the chart. If a second or third dose is needed at the one-hour mark, then a second dose will be given. If after the second dose the patient does not report sufficient pain control then a third dose will be given and the patient will be admitted to the hospital. The patient is free to opt out of the Ketamine pathway at any time and Opioids can be administered.
Interventions
DRUGStandardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.
This dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg/kg/dose.
OTHERStandard Care (in control arm)
Standard Care in Historical Control Group
Sponsors
University of Mississippi Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Mixed retrospective-prospective, single-center, non-randomized pragmatic pilot study of a standardized ketamine analgesia pathway
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis/pain crisis, Consent obtained
Exclusion criteria
* Ketamine allergy, Severe agitation/psychosis, Pregnancy, Hemodynamic instability (as judged by physician), Increased intracranial pressure, Severe hepatic impairment, Ketamine use within the previous 24 hours, Presentation for non-VOC-related pain (i.e. fever, acute chest syndrome, stroke, traumatic injuries etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids. | From time of patient enrollment and IRB approval for 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Emergency Department length of stay after using the Ketamine first pathway. | From time of patient enrollment and IRB approval until 36 months. |
| Pain score reduction in the acute setting after using a Ketamine first pathway as compared to Opioid first pathway. | From time of patient enrollment and IRB approval until 36 months. |
| Rate of repeat visits to the Emergency Department within 72 hours for pain after a Ketamine first pathway was followed. | From time of patient enrollment and IRB approval until 36 months. |
| Inpatient length of stay (in number of days) for to reach adequate length of stay. | From time of patient enrollment and IRB approval until 36 months |
| Adverse events experienced after using a Ketamine first pathway | From time of patient enrollment and IRB approval until 36 months. |
Countries
United States
Contacts
CONTACTCynthia Karlson, Ph.D.
PRINCIPAL_INVESTIGATORJohn N Freeman, MD
University of Mississippi Medical Center
Outcome results
None listed