title: Assessing age and gender in studies of breakthrough pain medications.
abstract: OBJECTIVE
  The present review was performed to identify possible differences observed between adults and elderly patients and between males and females in randomized clinical trials of breakthrough pain (BTP).
  
  
  METHODS
  A systematic search of the existing literature from 1998 to September 2013 was performed. Randomized clinical trials reporting data on older patients were selected.
  
  
  RESULTS
  Sixteen comparative studies were selected. The age range of inclusion criteria patients was mainly between 18-80 or ≥18 years. In some cases this data was unreported. The mean age of patients was 48-64 years, but information regarding the number of elderly patients was present in three studies only. Gender distribution was more or less 50%:50%. No subgroup analysis of efficacy or adverse effects of BTP medications for age and gender was reported.
  
  
  CONCLUSIONS
  There is a need for more information regarding the use of opioids for BTP according to age and gender.
authors.affiliation: La Maddalena Cancer Center , Palermo , Italy.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Mercadante
authors.forename: Antonino
authors.initials: A
authors.lastname: Giarratano
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000150:complications*; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid
keywords: Age; Breakthrough pain; Cancer pain; Fentanyl; Gender