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

1. Goal Setting

Identify your goals and expectations of treatment

Both passive and active goals should be evaluated
2. Preprocedure Planning

Baseline physical assessment, including functional mobility Administer lumbar puncture with bolus injection of Lioresal® Intrathecal

  • Standard dose is 50 mcg in 1 mL administered over a period of at least 1 minute
  • Small patients and those who rely on spasticity for functional mobility may respond to a 25 mcg bolus

Discussion of risks and side effects

Educate patients, family, and caregivers regarding what a successful screening test looks like*

3. Procedure

Assess spasticity and achievement of predetermined goals at least 2 times within the first 4 hours

Monitor patient for at least 8 hours (or as long as necessary) to ensure medical stability and recovery from hypotonia

If patient does not have a successful response, subsequent bolus doses in 25 mcg increments to a maximum of 3 total doses, may be tested after a minimum of 24 hours post initial bolus screening dose

4. After the Trial

Determine if screening trial was successful

Discuss with implanting team the starting dose, drug concentration, delivery mode, pump size, pump location, and catheter tip location

Discuss surgical and therapeutic plan with patient/family/caregiver, including preoperative plan through recovery and rehabilitation

Reinforce commitment, titration, and refill schedule with patient/ family/caregiver

*Development of realistic, individualized patient goals are recommended. These include both passive and active targets. The long term goals of ITB Therapy may not be fully realized during screening. Given the brief nature of the screening test, observed functional enhancement may be inconsistent, and patients may even demonstrate a decline in function due to the sudden alteration of the neuromuscular system; this observation does not represent a contraindicaton to chronic infusion, but such patients require careful dosing management and may need extended rehabilitation, which is important for attaining long-term functional improvement.1


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.

  1. Boster AL, Bennett SE, Bilsky GS, et al. Best practices for intrathecal baclofen therapy: screening test. Neuromodulation. 2016;19(6):616-622.
  2. 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.
  3. Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage


Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.