Complex Dosing Schedules for Continuous Intrathecal Baclofen Infusion Linda E. Krach, MD*, Robert L. Kriel, MD †‡ , and Andrea C. Nugent, MPH † The objective of the present study was to understand the clinical reasons for changes from simple continuous to complex (flex) dosing for tone reduction in individ- uals receiving intrathecal baclofen. Methodology was a retrospective chart review study of 164 individuals (95 male, 69 female) at a multi-specialty children’s hospital who were followed for at least 1 year for intrathecal baclofen management. Eighty-two persons were in the simple continuous only group and 82 also were on complex schedules at least once during the follow-up period. Mean age at most recent follow-up was 18 years and 0 months (median, 15 years and 8 months; stan- dard deviation, 8 years and 0 months; range, 6-45). The top three clinical reasons for switching dosing method were to (1) optimize intrathecal baclofen effect, (2) treat predictable daily tone variation, and (3) manage signs and symptoms of intrathecal baclofen withdrawal or underdelivery. In both groups, 90% of individuals had cerebral palsy, and mean baseline leg Ashworth scores were the same in both groups (mean, 3.7; standard deviation, 0.7). Mean total daily dose at chart review was higher in complex dosing (429.3 vs 211.9 g/day), as was mean follow-up time (4.8 vs 3.9 years). Case examples are presented. © 2007 by Elsevier Inc. All rights reserved. Krach LE, Kriel RL, Nugent AC. Complex dosing sched- ules for continuous intrathecal baclofen infusion. Pediatr Neurol 2007;37:354-359. Introduction Increased muscle tone is found in most persons with cerebral palsy [1]. Continuous intrathecal baclofen infu- sion is effective in reducing muscle tone of cerebral origin such as occurs in persons with cerebral palsy [2-11]. The pump system that is widely used allows the option of programming the pump to deliver medication at a constant or variable rate. Although this feature allowing for variable rate of delivery has been available for several years and has been discussed at meetings, there have been few journal publications describing clinical expe- rience using it. In a retrospective review of 50 patients receiving intrathecal baclofen, Rawlins [12] reported that this vari- able rate of delivery mode was used in 54% of patients and was the most common infusion mode in individuals with cerebral palsy. However, clinical rationale for its use was noted only for treatment of nighttime spasms in individu- als with multiple sclerosis [12]. A summary of a consensus conference discussed the use of complex programming options for variations in muscle tone during the patient’s typical 24 hour day [13]. A recent publication reported prolonged spasticity reduction with a single bolus of intrathecal baclofen [14]. The question arises whether this prolonged effect could be used clinically with those chronically receiving intrathecal baclofen. The objective of the present study was to understand the clinical reasons for changes from simple continuous to complex (flex) dosing for spasticity reduction in individ- uals receiving continuous infusions of intrathecal baclofen by programmable pump. Factors such as patient demo- graphics, clinical diagnosis, degree of spasticity, and provider were considered. Also, we provide illustrative case examples. Methods This retrospective descriptive study was conducted at Gillette Chil- dren’s Specialty Healthcare, a regional, multispecialty pediatric center in the Midwestern United States. Subjects in the present study represent a non-randomized, consecutive case series of children and adults who underwent pump implantation after January 1, 1999, and had at least 1 year of continuous treatment with intrathecal baclofen and follow-up at From *Pediatric Rehabilitation Medicine at † Gillette Children’s Specialty Healthcare and ‡ Pediatrics and Neurology at Hennepin County Medical Center, St. Paul, Minnesota. Communications should be addressed to: Dr. Krach; Pediatric Rehabilitation Medicine; Gillette Children’s Specialty Healthcare; 200 East University Avenue; St. Paul, MN 55101. E-mail: lkrach@gillettechildrens.com Received March 8, 2007; accepted June 27, 2007. 354 PEDIATRIC NEUROLOGY Vol. 37 No. 5 © 2007 by Elsevier Inc. All rights reserved. doi:10.1016/j.pediatrneurol.2007.06.020 ● 0887-8994/07/$—see front matter