IT PEDIATRIC BACLOFEN FOR DYSTONIA

Trial Protocol from Children's Hospital of Pittsburgh
August 1999

ROUTINE ORDERS
1. Regular diet unless specified.
2. Tylenol ______ mg p.o.q. 4prn.
3. Regular activity until intrathecal catheter placement.
4. Physostigmine available on floor.
5. A & B Monitor with EKG availability.
6. Pulse Oximetry for entire trial period.
7. Meds: Routine meds will be brought from home. MD must write for meds as per home schedule and write, "Family will use home supply".

Day 0 - Sunday


1. Admit to Peds.
2. Pediatric neurologist to do admission.
3. Orient to unit and protocol.
4. Rest of the day as per routine orders.
5. Anesthesia to verify signed consent or obtains consent if not obtained prior to admission.

Day 1 - Monday (OR)


12:00 a.m. NPO after midnight as per anesthesia for catheter insertion.
8:00 a.m. Speech evaluation if done prior to admission.
9:00 a.m. Patient to OR for catheter insertion.

Please be sure PT & SPEECH evals completed before pt goes to OR.


o A & B Monitor (Must have EKG)
o Pulse Oximetry
o Infusion of Baclofen to begin, 100 ug x 24 (500 ug/ml)
o Bedrest x 48 hr. HOB flat.
o Advance diet as tolerated, as per pedi neurologist.
o VS & Neuro status q 4 unless otherwise stated.


9:00 p.m. Baclofen may be increased after 12 by 50 ug/24 to a dosage of 150 ug/day until dystonia is obviously decreased as per pedi neurologist. If dystonia decreases, continue infusion at that dose until next PT evaluation.

Day 2 - Tuesday


* May increase by 50 ug every 8 hours unless improvement in dystonia or adverse event noted.

7:00 a.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 150 ug/day. If dystonia is not decreased, increase to 200 ug/day.


o APMS will check catheter site daily.
o A & B Monitor
o Pulse Oximetry
o Bedrest
o Regular Diet


3:00 p.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 200 ug/day. If dystonia is not decreased, increase to 250 ug/day.
11:00 p.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 250 ug/day. If dystonia is not decreased, increase to 300 ug/day.


Day 3 - Wednesday
7:00 a.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 300 ug/day. If dystonia is not decreased, increase to 350 ug/day.


o APMS will check catheter site daily.
o A & B Monitor
o Pulse Oximetry
o OOB when cleared by physician, with BR privileges as tolerated
o Regular Diet


3:00 p.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 350 ug/day. If dystonia is not decreased, increase to 400 ug/day.
11:00 p.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 400 ug/day. If dystonia is not decreased, increase to 450 ug/day.

Day 4 - Thursday
7:00 a.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 450 ug/day. If dystonia is not decreased, increase to 500 ug/day.


o APMS will check catheter site daily.
o A & B Monitor
o Pulse Oximetry
o OOB as per physician orders with BR privileges as tolerated
o Regular diet


3:00 p.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 500 ug/day. If dystonia is not decreased, increase to 550 ug/day.
11:00 p.m. Pediatric neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 550 ug/day. If dystonia is not decreased, increase to 600 ug/day.

Day 5 - Friday
7:00 a.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 600 ug/day. If dystonia is not decreased, increase to 650 ug/day.


o APMS will check catheter site daily.
o A & B Monitor
o Pulse Oximetry
o OOB as per physician orders with BR privileges as tolerated
o Regular diet


3:00 p.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 650 ug/day. If dystonia is not decreased, increase to 700 ug/day.
11:00 p.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 700 ug/day. If dystonia is not decreased, increase to 750 ug/day.

Day 6 - Saturday
7:00 a.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 750 ug/day, and contact Meg Barry, PT at home at 361-0418 for evaluation before patient is discharge. If dystonia is not decreased, increase to 800 ug/day.
APMS will check catheter site daily


o A & B Monitor
o Pulse Oximetry
o OOB as per physician orders with BR privileges as tolerated
o Regular diet


3:00 p.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 800 ug/day. If dystonia is not decreased, increase to 850 ug/day.

11:00 p.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 850 ug/day. If dystonia is not decreased, increase infusion to 900 ug/day, the maximum dosage for this protocol.


Day 7 - Sunday
7:00 a.m. Pediatric Neurologist to evaluate dystonia. If dystonia is obviously decreased, continue infusion at 900 ug/day. If dystonia is not decreased, continue infusion at 900 ug/day.


o APMS will check catheter site daily
o A & B Monitor
o Pulse Oximetry
o OOB as per physician orders with BR privileges as tolerated
o Regular diet


3:00 p.m. The trial is to be discontinued, APMS will remove the catheter and PT needs to evaluate the patient immediately after the catheter is removed. The Canadian Occupational Performance measure must also be administered. If the patient is a candidate for a pump, the plan needs to be discussed prior to discharge. Discharge pre pedi neurologist, and contact neuro surgery as needed.

CAUTION:
1. Patients must be on A & B monitor and pulse Oximetry 24/day.
2. Keep incisions covered with op-site. If dressings come off, notify APMS.
3. Notify APMS if catheter becomes dislodged or a catheter leak is noted.
4. Post signs on the patient's bed to alert other personnel of the intrathecal catheter.
APMS to obtain CSF C & S culture and Baclofen CSF level prior to catheter d/c.