INSTRUCTOR GUIDE FOR BACLOFEN WITHDRAWAL SIMULATION SCENARIO

  1. Title: Baclofen pump failure/Baclofen withdrawal
  1. Target Audience: Healthcare providers and teams who care for pediatric health emergencies, including but not limited to pediatric and emergency medicine residents, pediatric emergency medicine fellows, pediatric and emergency medicine physicians, nursing, respiratory therapy, and other allied health professionals.
  1. Overview

This case centers on an adolescent patient with altered mental status, agitation, and suspected intrathecal baclofen pump failure. Learners should recognize and appropriately manage suspected baclofen withdrawal, manage agitation and spasticity, demonstrate appropriate airway and circulatory management, appropriately consult subspecialists (including Physical Medicine and Rehabilitation and/or Neurosurgery), and provide patient disposition to a pediatric critical care unit.

  1. Purpose

This case was designed to teach emergency medicine physicians, pediatricians, and other healthcare providers about the clinical presentation, stabilization, and medical management of the patient with spasticity and agitation associated with suspected or proven baclofen withdrawal. Simulation was chosen because, in contrast to traditional lectures, it allows for team-based practice and fine-tuning of a systematic approach to acutely ill patients in a safe learning environment. The overall goal is enhanced recognition and management of pediatric patients with high-acuity, low-frequency toxicologic emergencies.

  1. Conceptual background

Prior to development of this simulation scenario, our fellowship included lecture-based teaching on toxicology topics based on the ACGME PEM core content outline. This case was developed to ensure a systematic opportunity for each trainee to practice acute recognition, differential diagnosis, evaluation, and management of toxicology emergencies.

A group of content experts from PEM and toxicology reviewed ACGME content guidelines for toxicology. This scenario was written initially by a single author, reviewed by multiple authors for content and clarity, piloted prior to the actual simulation day, and revised based on feedback.

  1. Implementation

This case requires use of Laerdal SimMan 3G and its associated software and program files, however a low-fidelity mannequin and simulation environment could also be used if verbal cues could be provided by instructors throughout the scenario. This scenario was conducted in a resuscitation room equipped with standard pediatric resuscitation equipment, including airway equipment, monitors and defibrillators, IV access, and standard resuscitation drugs. Participants were oriented to the mannequin and the resuscitation equipment prior to the scenario. This scenario was designed to take 10-15 minutes to complete with 30 minutes immediately following to debrief.

Scenario participants include 2-3 physicians and a nurse (who is also one of two confederates). One facilitator is needed to run the Laerdal software and 1-2 facilitators should serve as over-the-phone consultants and conduct a debriefing with the learning materials provided. This scenario calls for two confederates: one to play the role of the resident physician providing patient handoff and one nurse. The nurse confederate should have direct communication with a facilitator (via earpiece or in person) to assist in prompting participants when/if deviation from the scenario algorithm occurs. The nurse confederate is given notecards printed with specific physical exam findings and lab values to hand to participants when prompted (see Appendix C).

For our scenario, a cord attached from the mannequin’s arm to a bicycle brake was used to simulate spasticity, however this may also be provided to participants using notecards or verbal cues instead.

  1. Limitations

Mental status, capillary refill, and the presence or absence of neurologic manifestations are often difficult to simulate. Notecards and verbal cues should be provided by the confederate for clarity. Our workshop included only PEM fellows and nurses, and therefore has not been evaluated with other learner groups. We also did not include a didactic session with the scenario, but feel this may have been helpful to the participants’ overall learning experience.

  1. Learning Objectives
  2. Primary:
  3. Recognition and management of child with severe agitation and altered mental status
  4. Recognition and management of intrathecal baclofen (ITB) pump failure and withdrawal
  5. Reevaluation and care escalation of the decompensating patient with a labeled diagnosis at sign-out
  6. Assignment of team roles, including team leader
  7. Secondary:
  8. Demonstrate appropriate airway management
  9. Demonstrate appropriate circulatory support
  10. Demonstrate closed-loop communication and shared mental model
  11. Demonstrate appropriate subspecialty consultation with Neurosurgery, PM&R, and Toxicology/Poison Specialist
  12. Provide appropriate patient disposition and transition of care
  13. Critical Actions Checklist (see Appendix B, checklist)
  14. Establishment of team roles, including team leader
  15. Sign-out is received clearly by oncoming team with verbal review of lab work and radiologic studies performed
  16. Receptive and responsive to nursing staff’s concerns for patient’s increasing agitation
  17. Recognition of persistent agitation and altered mentation
  18. Timely placement of cardiac monitors and vital signs
  19. Basic airway management (Oxygen administration, BVM)
  20. Basic circulatory management (IV fluids administered)
  21. Considers differential diagnosis of altered mental status, agitation, and fever, including ITB failure, baclofen withdrawal, and infection
  22. Treatment ofagitation and withdrawal symptoms with benzodiazepinesand/or baclofen
  23. Additional labs requested (CK, u/a, urine myoglobin, blood culture)
  24. Recognition and appropriate management of rhabdomyolysis with IV fluids and sodium bicarbonate administration, antipyretics
  25. Poison Center or Toxicology consultation
  26. NSGY and PM&R consultations
  27. Disposition to pediatric intensive care unit
  28. Optimal sequence of critical actions: expected sequence as above
  29. Duration to critical actions: total scenario to be completed within 15 minutes of start
  30. Environment:
  31. Lab Set Up: This scenario has been run in the simulation lab in a large simulation room with control room. It could also be run in an emergency room, including in a resuscitation or trauma bay, a decontamination area, or a regular room.
  32. Mannequin Set Up:
  33. SimMan 3G (Laerdal) or similar adult-sized high-fidelity mannequin, with ability to simulate seizure
  34. Female adult patient, exam gown, adult diaper with dark cola spilled inside (to simulate hematuria), bilateral 6 mm pupils
  35. Lines needed: peripheral IV in place before scenario start
  36. Baclofen pump: shallow circular lid or tin (approximately 4-5 cm diameter) placed under manikin skin at region of right lower quadrant of abdomen
  37. Gastrostomy button (Mickey) trimmed and taped to left upper quadrant of abdomen, 4x4” gauze trimmed and secured around gastrostomy button
  38. Props:
  39. Basic airway and code cart
  40. Notecards with exam updates and lab results(see Appendix C)
  41. Xray: abdominal film with baclofen pump present
  42. Distracters:Team must recognize that patient with the labeled diagnosis of “possible appendicitis” (premature closure) at sign out requires reevaluation and escalation of care, and formulate a differential diagnosis for patient’s persistent agitation, fever, and tachycardia.
  43. Actors
  44. Roles:

Resident:provides sign-out to the team during rounds with script provided; portrays to the team that the patient likely has a diagnosis of appendicitis and does not mention baclofen pump failure as an alternate diagnosis.

Nurse: informs team about patient progression after sign-out; keeps scenario flowing by handing notecards to team lead with lab updates, physical exam specifics, and pointing out dark urine in diaper (if not noticed by team by Act 4)

  1. Who may play them:any medical provider with general experience in pediatric or emergency medical conditions
  1. Case Narrative (what the learner will experience)
  2. 17 year old female with cerebral palsy, developmental delay, seizure disorder, spasticity, and intrathecal baclofen pump is brought to the emergency center by her parents for agitation, spastic episodes, and fever. Parents associate agitation with abdominal cramping/pain. Pt has been in the EC for 12 hours, during which the present team gave an initial IV fluid bolus and morphine (10 hours ago). CBC showed leukocytosis with neutrophil predominance, normal chemistries,stable CXR and KUB, and a right lower quadrant abdominal ultrasound that could not visualize the appendix. The patient has been awaiting abdominal CT. The current EC team is at the end of their busy shift and the resident provides sign-out to the oncoming team. The resident is frazzled and clearly overwhelmed by his busy shift, provides a very limited sign-out without mentioning differential diagnosis, and has not been back in to reassess the patient in 4 hours. Parents have left the EC to eat dinner and run errands; they told the nurse they would be back in about an hour.

After sign-out is complete, the EC nurse reports to the team that the patient is becoming more agitated with tachycardia and fever. After initial exam and basic interventions (oxygen, IV fluid bolus, antipyretics), team considers differential diagnosis of fever, agitation, tachycardia (including status epilepticus, encephalitis, infection, baclofen withdrawal). Dark urine in diaper, along with additional labs (u/a, CK) reveal signs of rhabdomyolysis. Treatments include IV fluids with sodium bicarbonate, IV benzodiazepines, and/or dantrolene or cyproheptadine. Xray abdomen reveals intact intrathecal baclofen reservoir and tubing. Physical medicine and rehabilitation team evaluates baclofen reservoir which appears to be full. Neurosurgery is consulted and will take patient to the OR for exploration. Poison Center and/or toxicology consultation will have no other suggestions. Pt will require pediatric intensive care unit admission.

  1. Scenario Background given to participants
  2. Chief complaint, triage note:painful episodes and “acting strange” for 2 days, fever x 1 day
  3. Past medical history:

Spasticity and seizure disorder secondary to traumatic brain injury from a motor vehicle accidentat age 7. Developmental delay. History ofconstipation, asthma, and recurrent pneumonia. Pt followed by Neurology, neurosurgery, and physical medicine and rehabilitation.

  1. Past Surgical History:

Gastrostomy button and fundoplicationdone at 7 years of age; per parents, the patient still has her appendix.

Intrathecal baclofen pump placed by neurosurgeryat 14 years of age.

  1. Meds and allergies:

Levetiracetam 1000 mg per GT BID

Polyethylene Glycol 17 grams per GT BID

Ativan 1 mg per GT BID, prn agitation/spasticity

Clonazepam 1 mg per GT QHS, PRN sleep

Albuterol MDI 6 puffs every 4-6 hours, as needed for wheezing/cough

NKDA

  1. Family/social history; lives with mom, dad, 11 y/o sister. Has a home health nurse daily on weekdays; the patient has been on vacation with her parents for the past 3 weeks.
  1. Scenario conditions initially

Act 1:

Resident narrative: (at evening sign-out rounds…nervous, tired, and clearly overwhelmed after a busy shift): “This is a 17 year old female with a history ofcerebral palsy from a traumatic brain injury at age 7 after an MVC presenting with agitation, fever, and rapid heart rate x 24 hours, seems to have abdominal pain associated with these episodes. PMH: CP, seizure disorder, recurrent pneumonia, last admitted for pneumonia 4 months ago. Also has a history of constipation, on daily bowel regimen; last stool was yesterday and was large and soft. She has a gastrostomy tube and fundoplication, and has a baclofen pump. She’s been in the ER for 12 hours, and so far she’s had a CXR that is negative for pneumonia, a KUB with a moderate amount of stool present, and a CBC with a WBC of 19K with left shift, and normal chemistries. Our concern is that she may have acute appendicitis, so we got an ultrasound, which was not able to visualize the appendix, so we’re waiting for CT.”

(NO mention that this could be baclofen pump malfunction…fellow must sort through this information and consider other differential diagnoses for agitation and fever).

If prompted byteam leader, resident actor should use the following scripted answers:

“Pain medication?”—she had a dose of morphine this morning. I haven’t seen her in a few hours, though. I’ll go back in and see her before I leave to see if she needs any more.

“Antibiotics?”—Not yet. Do you want me to order some?

“IV fluids?”—yes, she had a bolus when she first got here. Her heart rate was in the 170’s, but she had a fever with it. I think she’s on maintenance now.

“Did they comment on the baclofen pump on the x-ray?”—I think so…oh, yeah. Radiology read it as stable with normal tubing.

“Has PM&R been consulted?”—I paged them a couple of times, but I haven’t heard back

“Has Neurosurgery been consulted?”—No. Um, I think we were waiting for the CT to come back first.

“When was her last baclofen dose change?”—Her dose has been the same for a long time, I think. I’m not sure what her dose is.

  1. Scenario branch points (see Appendix A, scenario algorithm)

ACT 2

Nurse narrative:(rushes over to team after sign-out, clearly worried and frantic): “I need a medical evaluation in room 7! The patient is back from CT and is extremely agitated and having spastic episodes. She hasn’t been reassessed by a doc in almost 4 hours. I haven’t put her back on monitors yet since she just came back from CT, but she’s just so agitated and won’t stop crying! Her parents stepped out to get something to eat and I can’t get a hold of them!”

Initial Exam:

Primary:

Vital Signs: HR 170 RR 30 T102 BP 130/90 Pox 95% RA

Airway: patent, delayed gag reflex, thick oral secretions

Breathing: tachypneic with shallow respirations

Circulation: warm, clammy extremities, brisk capillary refill;

Secondary:

HEENT: pupils 5-6 mm and reactive bilaterally, mucus membranes slightly tacky; poor oral hygiene

Lungs: clear bilaterally; tachypneic with shallow respirations

Cardiac: tachycardic, no murmur or gallop

Abdomen: abdomen slightly tense during spasms, gastrostomy site clean and dry without obvious signs of infection; baclofen pump site clean and dry

Extremities: spasticity noted in upper and lower extremities;

Skin: warm, diaphoretic; brisk capillary refill

Neurologic: Pt is alert but extremely agitated, cries intermittently, hyperactive startle reflex

ACT 3: Pt has a 1-minute spastic episode(seizure mechanism); she is crying and moaning in pain. Monitors should be placed. Pt should be given oxygen, IV fluids, and benzodiazepines. Differential diagnosis list should be verbalized.

ACT 4: Nurse actor informs teamthat physical medicine and rehabilitationhas assessed the baclofen pump and the reservoir is full, and they suggest neurosurgery evaluation (if not already done by then).If not recognized by participants, nurse actor points out that there is dark brown urine in diaper.

Labs on notecard provided to team lead by nurse actor when requested.

Treatments include NS bolus, IV fluids with bicarbonate, benzodiazepines, antipyretics, baclofen via gastrostomy tube.

ACT 5: Pt calms with benzodiazepineand baclofen therapy; Toxicology and/or Poison center consultation; ICU consultation and transfer

  1. Instructors Notes (what the instructor must do to create the experience)
  2. Tips to keep scenario flowing in lab and via computer

See triggers located on Scenario Algorithm, Appendix A, for changes in vital signs and mannequin findings.

Nurse actor provided with a headset to receive information directly from those running the computers/manikins. Actors are also given a set of notecards (Appendix C) to hold during scenarios with lab results and patient descriptors not apparent to the learners (e.g.capillary refill < 3 seconds; patient is agitated). Actors are directed over headset to give participants specific cards if prompted

  1. Tips to direct actors-Nurse actor provided with a headset to receive information directly from those running the computers/manikins. Actors are also given a set of notecards (Appendix C) to hold during scenarios with lab results and patient descriptors not apparent to the learners (e.g.capillary refill < 3 seconds; patient is agitated). Actors are directed over headset to give participants specific cards if prompted.
  2. Scenario programming-
  3. This scenario is easily run “on-the-fly” (without a program) by an experienced mannequin operator. The scenario management path, as well as potential complications and errors, are shown in Appendix A.
  1. Debriefing Plan
  2. Method of debriefing-The scenario was debriefed by physician simulation instructors who had been trained in debriefing methods including debriefing with good judgment and Advocacy-Inquiry. In addition, pediatric toxicologists participated in the debriefings as content experts.
  3. Actual debriefing materials- See Appendix B for Critical Actions Checklist, Appendix D for Debriefing Content.

Instructors watched the scenario using the Critical Actions Checklist, and used that to guide their debriefing.

The Debriefing Content form summarized the key medical information about baclofen overdose and withdrawal.

  1. Rules for the debriefing
  2. Basic Assumption-All learners are motivated, intelligent adults who are already well-trained, and are participating in the simulation to further their learning. Scenarios are chosen because they provide challenges that may be uncommon clinically, difficult, or critical. Mistakes are expected and welcomed as learning opportunities.
  3. Confidentiality-Performance in all simulations is confidential. The specific contents of the simulation should also be kept confidential.
  4. Fiction Contract-All learners and instructors agree to suspend disbelief and work to make the scenario as realistic as possible, recognizing that simulation is not the same as reality.
  5. Debriefings took place in a separate room from the scenario, and had video available for review as needed.
  1. Pilot Testing and Revisions
  2. Pilot Testing-completed at the Texas Children’s Hospital Simulation Center on July 21st, 2012.
  3. Participants: A total of 12 pediatric emergency medicine fellows and 4 pediatric emergency medicine nurses participated in the scenario, divided into 4 groups. At least 2 simulation faculty and 2 personnel members per scenario are required for a successful simulation experience.
  4. Performance expectations, anticipated management mistakes-Participants were informed that this was a non-graded interactive learning experience (similar to other simulation days they had previously experienced). They were informed that scenarios were chosen specifically to be challenging and that mistakes are both expected and welcomed as learning opportunities.
  5. Evaluation form for participants-All participant filled out a course evaluation at the end of the simulation day, which included specific feedback about scenarios, content, and instructors. Based on this feedback, scenarios were modified for future use.
  6. Scenario Revision: scenario revisions were performed in May 2013 and May 2014
  7. Authors and their affiliations
  8. Elaine Fielder MD, Department of Pediatrics, Section of Emergency Medicine, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX.
  9. Daniel Lemke MD, Department of Pediatrics, Section of Emergency Medicine, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX.
  10. Cara Doughty MD, MEd, Department of Pediatrics, Section of Emergency Medicine Baylor College of Medicine, Texas Children’s Hospital, Houston, TX.

/ n

Appendix B: Critical Actions Checklist