Mercadante, S., Villari, P., Ferrera, P., Casuccio, A., Mangione, S., & Intravaia, G. (2007). Transmucosal fentanyl versus intravenous morphine in doses proportional to basal opioid regimen for episodic-breakthrough pain. British Journal of Cancer, 96, 1828-1833.

IV morphine (IV-MO) and oral transmucosal fentanyl citrate (OTFC) given in doses proportional to basal opioid regimen. 53 couples of breakthrough events each treated with IV-MO and OTFC. Treatments were recorded. Patients were given both IV-MO and OTFC for each couple of breakthrough events. Order of administration was computer generated. Time between both pain flares was at least 6 hours. Doses of IV-MO 4 mg per 60 mg oral morphine basal and OTFC 200 µcg per 60 mg oral morphine basal.

25 patients with cancer receiving stable dose opioid. Patients were receiving doses of more than 60 mg morphine or equivalent, had acceptable pain relief, and had no more than twopain flares / day. Patients had pain flares between 700 and 1,900.

Comparative study

At episode (T0), 15 (T1) minutes and 30 minutes (T2) after treatment, pain intensity, and opioid-related symptoms were recorded. Decrease in pain intensity of at least more than 33% at T1, not requiring further treatment for next 2 hours was considered effective.

Episodes treated with IV-MO or OTFC showed a decrease in pain intensity. Statistical significance between interventions occurred at T1. AE were comparable

IV-MO and OTFC in doses proportionate to daily scheduled dose are safe and effective. IV-MO may have a shorter onset than OTFC.

Lack of blindness. No placebo control was considered. Double dummy was not feasible. Low number of participants is of concern and most likely due to drop out rates. However, strict inclusion criteria limit this bias.

OTFC given in doses proportionate to basal morphine was effective and safe. It is recommended to research this further.