What to Expect
A screening trial with Lioresal® Intrathecal (baclofen injection) first involves discussing goals and expected outcomes with the patient. Goals should be realistic and individualized to the specific condition and situation and may vary depending on the severity of spasticity.1
The screening test is done in an inpatient or outpatient setting while under medical supervision.1 On test day, the patient’s spasticity and function should first be assessed by physical examination.1 This serves as a “baseline” to measure changes in spasticity during the trial.1 Risks and possible side effects should also be discussed.1
The screening trial itself involves administration of a test dose of Lioresal® Intrathecal via a bolus injection into the CSF via catheter or a lumbar puncture procedure.2 The recommended screening dose of Lioresal® Intrathecal is 50 mcg/mL (available in a 1 mL ampule). The onset of clinical effect from a bolus screening dose of Lioresal® Intrathecal typically occurs in 30 to 60 minutes after injection. Peak effects are typically observed 4 to 6 hours postinjection.
Effects typically last 4 to 8 hours but vary depending on the patient’s symptom severity and the dose administered. They are always reversible.3
During this time, changes in spasticity and function should be monitored periodically.1
In the event that the initial dose of Lioresal® Intrathecal bolus injection produces less than desired response, another trial can be conducted 24 hours later using a higher dose. If the screening trial is unsuccessful, the procedure can be repeated with up to a total of 3 doses.1,3
The screening trial is required before receiving an implanted pump, but it is not a commitment to do so. You will discuss with your patient whether goals were met during the trial and if their condition is appropriate for further treatment with Lioresal® Intrathecal.1
Overview of the Lioresal® Intrathecal Screening Trial1,3
Screening Trial Procedure
Before pump implantation and initiation of chronic infusion of Lioresal® Intrathecal, patients must demonstrate a positive clinical response to a bolus dose of Lioresal® Intrathecal administered intrathecally. This is done by providing an initial bolus dose containing 50 mcg in a volume of 1 mL into the intrathecal space by barbotage over a period of not less than 1 minute. The patient should then be observed for the next 4 to 8 hours for a positive response. If the response is less than desired, the patient may be administered a second bolus injection 24 hours after the first. The second screening bolus injection dose should be 75 mcg in 1.5 mL, and the patient should again be observed for the next 4 to 8 hours. A third and final bolus screening dose of 100 mcg in 2 mL can be administered 24 hours later if the response is still inadequate.3
For pediatric patients, the same screening dose of 50 mcg in 1 mL used in adults is also recommended. However, in very small patients, a screening dose of 25 mcg may be tried first. Any patient who does not respond to 100 mcg bolus screening dose should not be considered a candidate for chronic infusion with an implanted pump.3
Location and Equipment
Screening trials can be conducted in any location that ensures the safe delivery of medication, allows for adequate patient monitoring, and provides the treatment team to evaluate the results of the ITB bolus dose based on the goals and expectations agreed upon prior to the screening trial.1 Potential sites for trial include inpatient facilities (eg, hospital, rehabilitation center), ambulatory or surgical centers, or outpatient clinics.1
Equipment needed may include a hospital bed or stretcher and resuscitative equipment should be available. Experts suggest fluoroscopy (for patients with previous spinal fusion surgeries) or ultrasound guidance to facilitate the lumbar puncture, and checking cardiopulmonary parameters frequently during the first 2 hours after injection.1
It is mandatory that all patients, caregivers, and treating physicians receive adequate information regarding the risks of the mode of treatment. Instruction should be given on signs and symptoms of overdose, procedures to be followed in the event of an overdose, and proper home care of the pump and insertion site.
- Boster AL, Bennett SE, Bilsky GS, et al. Best practices for intrathecal baclofen therapy: screening test. Neuromodulation. 2016;19(6):616-622.
- Francisco GE, Saulino M. Chapter 19: Intrathecal baclofen for spasticity. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016.
- Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.