Low Dose Bolus Ketamine For Use In Sickle Cell Pain Crisis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-21
SponsorUniversity of Mississippi Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed Sickle Cell Disease (any genotype), Presenting to the Emergency Department with Vaso-occlusive crisis/pain crisis, Consent obtained
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Standardized Low-dose bolus IV Ketamine within 30 minutes of arrival and every 1 hour as needed for max of 3 doses.
DrugThis dosing is based off of Ideal body weight of each patient and dosed at 0.3 mg/kg/dose.
Standard Care (in control arm)
Other interventionStandard Care in Historical Control Group
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Any patient with confirmed Sickle Cell Disease in pain crisis.Experimental treatment 1 intervention
Group B: Retrospective Historical Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Hospital admission rates after using a Ketamine first pathway as compared to after the use of Opioids.
Time frame
From time of patient enrollment and IRB approval for 36 monthsSecondary outcomes
1
Emergency Department length of stay after using the Ketamine first pathway.
Time frame
From time of patient enrollment and IRB approval until 36 months.2
Pain score reduction in the acute setting after using a Ketamine first pathway as compared to Opioid first pathway.
Time frame
From time of patient enrollment and IRB approval until 36 months.3
Rate of repeat visits to the Emergency Department within 72 hours for pain after a Ketamine first pathway was followed.
Time frame
From time of patient enrollment and IRB approval until 36 months.4
Inpatient length of stay (in number of days) for to reach adequate length of stay.
Time frame
From time of patient enrollment and IRB approval until 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: