Assessing age and gender in studies of breakthrough pain medications

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. Conclusion: There is a need for more information regarding the use of opioids for BTP according to age and gender.