Fulfill FDA Regulations And Maintain Compliance With BrainCloud, Which Offers Direct Mapping of Spravato Requirements And Treatment Parameters Within Our Software

The use of ketamine in managing treatment resistant depression has captured considerable attention, both from psychiatrists and other physicians. In fact, the FDA allowed “fast track” status for esketamine (Spravato, Janssen Pharmaceuticals) via intranasal administration; in February, 2019, the expert review panel voted overwhelmingly in favor of allowing the marketing of esketamine in the U.S. [1] [2] and the FDA approved domestic marketing on March 5th, 2019 [3].

BrainCloud supports not only intranasal administration of racemic ketamine, but also use of Spravato in compliance with the FDA's mandatory REMS (Risk Evaluation and Mitigation Strategy) program. In particular, BrainCloud will ensure that a practice's use of Spravato is accurately and thoroughly documented, with recording of REMS registrations, vital signs, and clinical status at the end of the mandatory observation period.

Treatment Parameters (1/3):


Treatment Parameters (2/3):


Treatment Parameters (3/3):


View Each Patient's Spravato REMS Registration Status
(In BrainCloud):


BrainCloud Reflects Exact Registration Requirements and Helps Maintain Compliance:


Control Which User Accounts Can Access, Enter, and Save
Spravato Treatment Parameters:


Intranasal Ketamine

(Including Esketamine/Spravato)

Track Intranasal Ketamine

BrainCloud includes an entire workflow to help your practice efficiently and accurately calculate an intranasal ketamine treatment's parameters.

How many insufflation rounds are there in this treatment session?
How many nostrils are insufflated per insufflation round?
Therefore, how many total insufflations are there in this treatment session?
How many total milligrams of ketamine will be administered in this treatment session?
How many milligrams of ketamine are administered per insufflation round?
How many milligrams of ketamine are administered per nostril per insufflation round?
What is the order of nostrils to be insufflated?
What is the wait time between insufflation rounds?
What is the wait time between insufflating each nostril within a round?
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Intranasal Ketamine Parameters

Dosing Multiplier (mg of ketamine per kg of body weight)
One or More Rounds of Insufflations
Number of Nostrils Insufflated Per Round
Total Ketamine (mg) Administered Over a Treatment Session
Total Ketamine (mg) Administered Per Insufflation Round
Total Ketamine (mg) Administered Per Nostril Per Insufflation Round
Wait Time Between Insufflating Each Nostril Within An Insufflation Round
Patient Body Weight (kg)
Insufflated Nostril Side
Insufflated Nostril Condition
Patient Body Weight (lb)
Procedure Notes
Ketamine Administration Time
Wait Time Between Insufflation Rounds

Treatment Timeline

BrainCloud excels at organizing and simplifying a patient's treatment history. Within a ketamine Treatment Course, every intravenous and intranasal treatment session and relevant parameters are shown on a timeline for quick summaries of how treatments are progressing.


Intravenous Ketamine


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Track Ketamine Infusions

BrainCloud features an entire workflow to help your practice efficiently and securely track patient progress throughout a series of IV ketamine treatments.

A patient or their insurance will pay for some number of intravenous ketamine treatment sessions. BrainCloud groups these sessions into a "Treatment Course," which spans the length of time between the first and last treatment session.

Intravenous Parameters

BrainCloud allows clinicians to easily manage and organize both basic and clinical data as to the when, where, how, and who of an intravenous ketamine treatments.

Dosing multiplier (mg of ketamine per kg of body weight)
IV Placement (body side) during infusion (left or right)
IV placement (body location) during infusion (neck, upper Upper or Lower Extremity)
IV gauge size
Patient weight (In kilograms and pounds)
Auto-calculated total IV ketamine per treatment session
A robust text and formatting editor for treatment session and administration notes

Intramuscular Ketamine


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Intramuscular Parameters

As some clinicians choose to administer ketamine via intramuscular injection, BrainCloud allows clinicians to easily manage and organize the relevant data for each treatment, such as the when, where, how, how much, and who performed the treatment.

Dosing multiplier (mg of intramuscular ketamine per kg of body weight)
Injection side of the body (left or right)
Injection location (arm, flank, buttock, or orther)
Patient weight (in kilograms and pound)
Auto-calculated/target dose (using the patient weight and dosing multiplier, e.g.: if a patient weights 70kg, then using 3mg/kg, the auto-calculated value suggests that a total injection dose of 210 mg):
The actual dose administered (if deviating from the auto-calculated/target dose)
A robust text and formatting editor for treatment session and administration notes
Injection Locations Arm Buttock Flank Other

Record Vital Signs

Before, During, and After Treatment Sessions


Vital Signs

While most anesthetic medications may produce a lowering of blood pressure and heart rate, ketamine is known to have potential to increase these vital sign metrics, so close monitoring is important to the safe use of this medication.

BrainCloud supports tracking of vital signs at whatever interval the physician selects. This includes an entire workflow to help your practice efficiently and accurately calculate an intranasal ketamine treatment's parameters.

Standard Protocols

Create Pre-Filled Treatment Parameters | Select To Auto-Fill When Creating A New Treatment Session

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Think of These Like Templates

The safe delivery of ketamine, via any route, requires planning for the medication to be administered over time.

A practice may want to lay out a protocol for an entire course of ketamine treatments, including doses and target intervals between treatments. Such a protocol might specify a dose parameter and a target schedule.

If changes need to be made for a given session, any deviation from what was ordered will be highlighted, and a notes field is available to document why a change was made (e.g., dose reduced due to elevated blood pressure).

Select and Apply Quickly

"Standard Data" in BrainCloud is simply a way of saving some or all data for an intravenous or intranasal treatment session. By pre-populating certain fields, time is saved, and therefore more time is available for more treatments.



Timelines and Notes

Everything In One Place

Each ketamine treatment course can feature one or more of intranasal, Spravato/esketamine, intramuscular, or intravenous ketamine. In once place, you can find a patient's payment history for sessions within that treatment course, data on what parameters were applied in each treatment session, the relationship between symptom rating scales and treatment parameters, and more.

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Treatment Notes and Data: Auto-Organized.

Physician notes can be entered with a mix of free-text and structured responses, to fit the individual physician’s preferences and needs. Templated intake evaluations, progress notes (“SOAP” notes), treatment procedure notes, and other notes (phone interaction, medication refill request) make it easy to meet documentation expectations and requirements.

Additional integral “therapy notes” can be maintained by providers while not being made available to insurers in a routine production of treatment notes.


See outcomes and adjust accordingly. BrainCloud's ketamine charts display calculated dosages for the patient's weight and other factors, what the practitioner actually delivered in total per treatment session, and the patient's weight each treatment session. Visualizing this information may help a patient better understand their treatments or can demonstrate to a third party payor the benefits of a particular type of treatment for a particular individual.