Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen
Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise
controlled pain. Breakthrough pain is common in patients with advanced cancer. Current
medications to treat breakthrough pain include oral immediate release opioid formulations
and more recently oral transmucosal fentanyl citrate.
The pain pen study is a randomized controlled double blind cross-over study comparing the
efficacy of oral immediate release morphine with that of subcutaneous hydromorphone,
injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary
experience with the pain pen suggests that it has a more rapid time of onset of pain relief
than oral formulations.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Pain intensity difference (PID) at t=15 minutes
Joost L. Jongen, MD
Dept. Neurology, Erasmus MC
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)