Brooklyn, New York 11201


Purpose:

Pain associated with sickle cell disease is a common emergency department visit. It is also frequently associated with a high emergency department recidivism rate for pain control and admissions to the hospital. Opiates are considered the first line therapy for acute flares and to manage chronic pain. This often times leads to a stigma of being "opiate seekers" or "frequent fliers". With this study, we wish to explore whether adding ketamine to standard acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates while improving the patient's perception of pain. In addition, we will be exploring whether ketamine as an adjuvant therapy can help reduce hospital admissions for the management of acute sickle cell crisis pain.


Study summary:

The total number of required patients would be 53 per arm (106 patients). The targeted study population is patients who are 18 years old or older presenting with acute sickle cell crisis pain either described as diffuse throughout the body or localized to extremity/back. The expected duration of the study is 2 years Prior to initiation of study, the research associates would be responsible for the randomization process. The goal of this study is to enroll 106 patients total (53 per arm). Patients will be assigned to a study arm via an online random-number generator (http://www.randomization.com). Each number will correlate to a sealed opaque envelope, which will be pulled in sequential order as patients are enrolled. Within each envelope will contain the particular study medication. A primary master list will be kept in a locked and secured cabinet in pharmacy. Only pharmacy personnel and the primary/secondary investigators will have access to this list. Pharmacy will use this master list to prepare study medications. A second master list would also be secured in the EM research room for back-up purposes. The secondary master list would be assessed only if the primary master list is lost. Only the primary and secondary investigator will have access to the secondary master list. Detailed study procedures: Step 1: Identification of patients with chief complaints or visit reasons of sickle cell via the Emergency Department's Statusboard by Research Associate or study investigators. Step 2: Screening of potentially eligible patients with inclusion/exclusion criteria checklist as per Data Collection instrument (See attached Form 1) by Research Associate or study investigators. Step 3: If patient is eligible, Research Associate or study investigators would obtain informed consent and explain potential risks and benefits with receiving study interventions. Step 4: There will be no placebo only arm. All providers, except pharmacy, will be blinded to whether the patient is receiving ketamine or saline. All patients will receive conventional standard therapy (dilaudid or morphine) which will be ordered by the emergency department resident or attending. Each patient will receive an IVP bolus with infusion and a separate IVP. Arm A will include 0.3 mg/kg IVP bolus of Ketamine followed by a 0.1 mg/kg/hr infusion for 3 hours along with an initial dose of standard therapy. Arm B will receive a IVP bolus of normal saline (utilizing the 0.3 mg/kg calculation) followed by a normal saline infusion and then a separate standard therapy dose. Step 5: An order would be placed by the medical resident, medical attending, a study investigator who is a physician, or a pharmacist under the permission of the attending physician into Allscripts for a study intervention. Step 6: Upon receiving the order in Allscripts, the order would be verified by the pharmacy. Once notified of which envelope has been pulled pharmacy will prepare a ketamine IVP bolus and infusion or NS IVP bolus and infusion. Conventional therapy will be pulled from the general ED accudose stock by the ED RN. ED personnel will obtain the infusion preparation from pharmacy. It will be labeled for the patient, with study number, but without other identifying marks. When the study medication is picked up, pharmacy will open the sealed envelope to confirm which medication arm was prepared in order to internally verify the correct preparation. Step 7: The nurse assigned to the patient would administer the intervention. Step 8: A research associate or a study investigator would approach the patient to assess and record primary outcomes, secondary outcomes at designed time intervals. The data will be recorded on the data collection instrument. If additional medication is requested by the patient, the orders would be placed by the medical resident or attending who are assigned to the patient in the ED. Step 9: All data retrieved from the paper data collection sheets will be transcribed into an encrypted and password protected electronic database by the research associate. • All patient identifiers would be de-identified in the database. All participants would be assigned a study participant number.This database would be stored in the Emergency Department faculty or research room. Only the research associates or study investigators would have access to the electronic database. The paper data collection sheets would be stored in a stationary and locked cabinet in the Emergency Department for safe keeping. At the end of the study, these records will be maintained according to the hospital's record-retention policy. Step 10: At the end of study enrollment, the data will be analyzed. Blinding will be removed for final data analysis and compilation. Step 11: At the conclusion of the study, the final results and conclusions would be presented to the IRB. All data recorded from paper would be shredded and destroyed. All data recorded on electronic databases would be deleted.


Criteria:

Inclusion Criteria: - Patients 18 years old and older presenting with acute sickle cell crisis pain either described as diffuse throughout the body or localized to joint/extremity/back - Describes pain to be greater than or equal to 2 on the NRS - Consents to IV access - Provides informed consent Exclusion Criteria: - Receiving IM therapy only - Standard therapy plan is not morphine or dilaudid - Previous enrollment in study - Documented fever or subjectively reported fever - Complaint of chest pain or shortness of breath or abdominal pain or headache - Suspicion for acute chest crisis - Patients with history or acute diagnosis of subarachnoid hemorrhage/increased intracranial pressure - Severe hypertension(≥180/100) - History of CAD or hypertension - Presence of/suspected for traumatic head injury with or without loss of consciousness - Presence of/suspected for myocardial ischemia - Presence of/suspected for alcohol intoxication - Hemodynamic instability - History of psychiatric disorders, - Known or suspected pregnancy or breastfeeding - Allergy to ketamine - Administration of opioids in previous 4 hours - Patients with language barriers - Ilicit drug use within the past 7 days


NCT ID:

NCT02417298


Primary Contact:

Principal Investigator
Michael Hochberg, MD
The Brooklyn Hospital Center

Billy Sin, Pharm.D.
Phone: 718-250-6250
Email: bis9016@nyp.org


Backup Contact:

Email: mih9089@nyp.org
Michael Hochberg, MD


Location Contact:

Brooklyn, New York 11201
United States

Billy W Sin, Pharm.D.
Phone: 718-250-6250

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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