title: Effective treatment of spasticity using dronabinol in pediatric palliative care.
abstract: BACKGROUND
  Cannabis extracts have a wide therapeutic potential but in many countries they have not been approved for treatment in children so far.
  
  
  OBJECTIVE
  We conducted an open, uncontrolled, retrospective study on the administration of dronabinol to determine the value, efficacy, and safety of cannabis-based medicines in the treatment of refractory spasticity in pediatric palliative care.
  
  
  METHODS
  Sixteen children, adolescents and young adults having complex neurological conditions with spasticity (aged 1.3-26.6 years, median 12.7 years) were treated with dronabinol by our specialized pediatric palliative care team between 01.12.2010 and 30.04.2015 in a home-care setting. Therapeutic efficacy and side effects were closely monitored.
  
  
  RESULTS
  Drops of the 2.5% oily tetrahydrocannabinol solution (dronabinol) were administered. A promising therapeutic effect was seen, mostly due to abolishment or marked improvement of severe, treatment resistant spasticity (n = 12). In two cases the effect could not be determined, two patients did not benefit. The median duration of treatment was 181 days (range 23-1429 days). Dosages to obtain a therapeutic effect varied from 0.08 to 1.0 mg/kg/d with a median of 0.33 mg/kg/d in patients with a documented therapeutic effect. When administered as an escalating dosage scheme, side effects were rare and only consisted in vomiting and restlessness (one patient each). No serious and enduring side effects occurred even in young children and/or over a longer period of time.
  
  
  CONCLUSIONS
  In the majority of pediatric palliative patients the treatment with dronabinol showed promising effects in treatment resistant spasticity.
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany. Electronic address: michaela.kuhlen@med.uni-duesseldorf.de.
authors: Michaela
authors: M
authors: Kuhlen
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany.
authors: Jessica I
authors: JI
authors: Hoell
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany.
authors: Gabriele
authors: G
authors: Gagnon
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany.
authors: Stefan
authors: S
authors: Balzer
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany.
authors: Prasad T
authors: PT
authors: Oommen
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany.
authors: Arndt
authors: A
authors: Borkhardt
authors: University of Dusseldorf, Medical Faculty, Department of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Moorenstr. 5, 40225 Dusseldorf, Germany.
authors: Gisela
authors: G
authors: Janßen
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D013759:Dronabinol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009129:Muscle Tonus / Q000187:drug effects; D019636:Neurodegenerative Diseases / Q000150:complications / Q000188:drug therapy; D010166:Palliative Care / Q000379:methods*; D012189:Retrospective Studies; D013727:Terminal Care; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013759:Dronabinol
keywords: Dronabinol; Pediatric palliative care patients; Spasticity