title: Efficacy and safety of transdermal buprenorphine in the management of children with cancer-related pain.
abstract: BACKGROUND
  The current study investigated the efficacy, safety, tolerability, and compliance of a transdermal buprenorphine delivery system for the management of chronic cancer pain in the pediatric population.
  
  
  METHODS
  Sixteen pediatric patients with moderate to severe cancer-related pain not satisfactorily controlled with previous non-opioid therapies were enrolled. Transdermal buprenorphine was administered following a 72 hour schedule and rescue medication (tramadol) was allowed for breakthrough pain. Pain intensity was assessed using the Wong-Baker faces pain rating scale (WBS) and other parameters related to the global quality of life were evaluated. Children's evaluations of efficacy, compliance, and tolerability were recorded using numerical scales. Adverse events were monitored during the study and the medications needed to control opioid-related nausea and constipation were recorded.
  
  
  RESULTS
  Eleven patients (68.75%) responded to transdermal buprenorphine after 2 weeks of treatment. Pain intensity measured with WBS decreased from 6.25 at baseline to 1.38 at Day +60 (P < 0.001). All outcome measures of global quality of life (quality of sleep, alimentation, play and activity, speech, and crying) significantly improved over the 60-day study period. Children's evaluations of compliance and tolerability of the drug were always positive over the entire period of treatment. No severe adverse events were recorded. Opioid-related nausea was well controlled with medication on request, and the need for laxative therapy was greater at the end of the second month of treatment.
  
  
  CONCLUSIONS
  Transdermal buprenorphine was found to represent an efficient, safe and well tolerated approach to the management of children's chronic cancer pain.
authors.affiliation: Division of Pediatric Oncology, A. Gemelli Hospital, Catholic University of Rome, Rome, Italy. ruggiero@rm.unicatt.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Ruggiero
authors.forename: Paola
authors.initials: P
authors.lastname: Coccia
authors.forename: Roberta
authors.initials: R
authors.lastname: Arena
authors.forename: Palma
authors.initials: P
authors.lastname: Maurizi
authors.forename: Andrea
authors.initials: A
authors.lastname: Battista
authors.forename: Vita
authors.initials: V
authors.lastname: Ridola
authors.forename: Giorgio
authors.initials: G
authors.lastname: Attinà
authors.forename: Riccardo
authors.initials: R
authors.lastname: Riccardi
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects*; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000188:drug therapy*
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine