ABSTRACT
Few data exist in the literature to support the use of high dosages of oral baclofen and clonidine that are frequently required to treat children with spasticity. This study was a retrospective chart review of baclofen and clonidine dosages used in children diagnosed with cerebral palsy or traumatic brain injury. The primary objective was to calculate the mean dosages of baclofen and clonidine based on the duration of spasticity postinjury. Secondary objectives included determining correlations between dosage and age, injury type, location of spasticity, comorbid seizures, or concomitant antispasticity medications. Eighty-seven children receiving baclofen and/or clonidine were included in this study. Mean dosages of 40 mg/day (n = 86) and 0.4 mg/day (n = 31) were required for baclofen and clonidine, respectively. The maximum dosage was 240 mg/day for baclofen and 3.6 mg/day for clonidine. Duration postinjury, age, and concomitant antispasticity medications were the most predictive variables for baclofen dosage as a model (r = .522; P = .000). Duration postinjury and location of spasticity were the most predictive variables for clonidine dosage as a model (r = .523; P = .000). The average dosages of baclofen and clonidine used in this population of children with cerebral palsy or traumatic brain injury were similar to those reported in the literature, with higher maximum dosages found in this investigation.
Subject(s)
Baclofen/administration & dosage , Central Nervous System/drug effects , Clonidine/administration & dosage , Muscle Spasticity/drug therapy , Muscle, Skeletal/drug effects , Administration, Oral , Adolescent , Adrenergic alpha-Agonists/administration & dosage , Adrenergic alpha-Agonists/adverse effects , Adult , Age Factors , Baclofen/adverse effects , Brain Injuries/drug therapy , Brain Injuries/physiopathology , Central Nervous System/physiopathology , Cerebral Palsy/drug therapy , Cerebral Palsy/physiopathology , Child , Child, Preschool , Clonidine/adverse effects , Dose-Response Relationship, Drug , Drug Synergism , Drug Therapy, Combination , Female , GABA Agonists/administration & dosage , GABA Agonists/adverse effects , Humans , Infant , Male , Muscle Spasticity/etiology , Muscle Spasticity/physiopathology , Muscle, Skeletal/innervation , Muscle, Skeletal/physiopathology , Retrospective Studies , Time Factors , Treatment OutcomeABSTRACT
The objective of the Registry was to characterize the population of infants receiving prophylaxis for respiratory syncytial virus (RSV) disease by describing the patterns and scope of usage of palivizumab in a cross section of US infants. RSV hospitalization outcomes were also described. The Palivizumab (Synagis, MedImmune, Inc., 25 West Watkins Mill Road, Gaithersburg, MD 20878) Outcomes Registry was a prospective multicenter survey conducted at 63 sites. Demographics, injection history, and RSV hospitalization outcomes were collected on 2,116 infants receiving palivizumab. Infants were enrolled in the Registry between September 1, 2000-March 1, 2001, at the time of their first injection. Infants born at less than 32 weeks of gestation accounted for 47% of infants enrolled, and those between 32-35 weeks accounted for 45%; approximately 8% were greater than 35 weeks of gestation. Lower RSV hospitalization rates were observed in infants who had greater adherence to regularly scheduled injections. Nearly one-half of all hospitalizations occurred within the first and second injection intervals, suggesting the importance of early RSV protection. The confirmed RSV hospitalization rate of all infants in the Registry was 2.9%; the rate was 5.8% in infants with chronic lung disease of infancy, and 2.1% in premature infants without chronic lung disease. In conclusion, these data support the continued effectiveness of palivizumab prophylaxis for severe RSV lower respiratory tract disease in a large cohort of high-risk infants from geographically diverse pediatric offices and clinics. The Palivizumab Outcomes Registry provides an opportunity to assess palivizumab utilization and clinical effectiveness in the US.
