IT BACLOFEN TRIAL for
PEDIATRIC SPASTICITY PROTOCOL

from Children's Hospital of Pittsburgh, August 1999

Day 1


1. Book patient as outpatient in ASU - Baclofen study. Baclofen injection will be done in PACU with 8 hours of observation time. Trials will be set up to be done on Monday, Tuesday and Wednesday.
2. Check to make sure consents have been signed for the trial.
3. Diagnosis: Spasticity of Cerebral Origin.
4. Condition: Good.
5. Diet: Regular unless otherwise indicated.
6. Meds: Tylenol _____ mg p.o./p.r. q. 4 hr. prn.
Home meds
Physostigmine 2mg/ vial at bedside (Dose Range:0.02mg/kg physostigmine intravenously, do no give more than 0.5mg/min, this dose may be repeated at 5-10 minute intervals until therapeutic effect is obtained or maximum of dose of 2 mg is attained)
7. Activity: ad lib until after injections and then flat for 2 hours.
8. Allergies: as indicated.
9. Vital signs: per floor routine until after injection and then q. 1 hr x 8 hrs.
10. Have L.P. tray at bedside in PACU. (whitacre needle 20 or 22 gauge)
11. Obtain Baclofen 50 ug IT from the pharmacy
12. Notify Physical Therapist prior to injection so that patient can be evaluated for baseline tone.
13. Anesthesiology member to inject Baclofen.
14. PT to assess tones as requested per patient's physician, i.e. every two hours after injection times 8 hours.
15. A & B Monitor x 8 hours after injection.
If response noted, study stops. If no response to 50 ug of Baclofen, proceed to Day 2.

Day 2 (If no response)
1. Diet - no change.
2. Meds - no change.
3. Activity - no change.
4. Vital Signs - no change.
5. Have L.P. tray at bedside in PACU (whitacre needle 20 or 22 gauge)
6. Obtain Baclofen 75 ug IT from pharmacy.
7. Notify PT prior to injection to evaluate tones.
8. Anesthesiology member to inject Baclofen.
9. PT to assess tone as ordered after injection
10. A & B Monitor x 8 hours after injection.

If no response noted, study stops. If no response to 75 ug of Baclofen, proceed to Day 3.
Day 3
1. Diet - no change.
2. Meds - no change.
3. Activity - no change.
4. Vital Signs - no change.
5. Have L.P. tray at bedside in PACU (whitacre needle 20 or 22 gauge)
6. Obtain Baclofen 100 ug IT from pharmacy.
7. Notify PT prior to injection to evaluate tones.
8. Anesthesiology member to inject Baclofen.
9. PT to assess tone after injection
10. A & B Monitor x 8 hours after injection.
9. Study complete after completion of 8-hour evaluation, contact anesthesia for D/C orders.