Mercadante, S., et al., A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin, 2009[12]
This is a landmark trial regarding intranasal fentanyl for the treatment of breakthrough pain. The authors randomized 139 patients to either oral transmucosal fentanyl – OTFC (Actiq) versus intranasal fentanyl (Instanyl) in a cross over trial where the patients served as their own control by being subjected to both treatments. Instanyl is a highly concentrated form of fentanyl – ranging from 500 mcg/ml to 2000 mcg/ml delivered at a 0.1 ml dose of 50 to 200 mcg) into one nostril, with the option of a second dose at 10 minutes via an atomizer device. Patients had to have cancer associated breakthrough pain occurring at least 3 times per week to be eligible. In the initial part of the trial they had a dose titration phase to determine both the proper dose of Actiq and of Instanyl to control their usual pain – this dose was then used for treatment of breakthrough pain during the randomization phase. Once dosing was determined patients were treated with either method for a maximum of 2 weeks until they had used the study drug 6 times, at which point they crossed over and used the alternate drug six times. The patients were not blinded to the treatment medication. The primary outcome was time until meaningful pain reduction as per patients opinion. Secondary outcome was pain relief based on a numerical rating scale (0 to 10) with time to achieving at least 33% reduction and 50% reduction recorded.
