Bhatnagar, S., Devi, S., Vinod, N.K., Jain, P.N., Durgaprasad, G., Maroo, S.H., & Patel, K.R. (2014). Safety and efficacy of oral transmucosal fentanyl citrate compared to morphine sulphate immediate release tablet in management of breakthrough cancer pain. Indian Journal of Palliative Care, 20, 182–187. 

To compare the efficacy and safety of transmucosal fentanyl and oral morphine for breakthrough pain

Patients were randomized to receive 200 mcg of transmucosal fentanyl or 10 mg immediate-release oral morphine when needed for breakthrough pain for three days. Patients were hospitalized during the study for monitoring. The intensity of breakthrough pain was assessed at time 0 and at 5, 15, 30, and 60 minutes after receiving the study drugs.

• N = 186  
• MEAN AGE = 47.7 years
• MALES: 54%, FEMALES: 46%
• KEY DISEASE CHARACTERISTICS: Not reported
• OTHER KEY SAMPLE CHARACTERISTICS: The bseline intensity of persistent pain was 4.92–5.17, and the intensity of breakthrough pain was 7.85–8.11.

• SITE: Multi-site  
• SETTING TYPE: Inpatient    
• LOCATION: India

• APPLICATIONS: Palliative care

Open-label, randomized trial with an active control

• Numeric Rating Scale (NRS) for pain intensity

Oral transmucosal fentanyl had a more rapid onset with better pain relief at 15 minutes. 56% of breakthrough episodes treated with fentanyl had a greater than 33% reduction in pain intensity at 15 minutes compared to 39% of episodes treated with morphine (p < 0.0001). Rescue medication was needed in 2.1% of patients receiving fentanyl and no patients using morphine. This difference was not significant. No adverse events were reported in either group. At all assessment time points, those receiving fentanyl had a lower pain intensity.

Oral transmucosal fentanyl citrate was effective in reducing the intensity of breakthrough pain more quickly than oral morphine sulfate with no adverse events.

• Risk of bias (no blinding)
• Other limitations/explanation: Short study duration

Oral transmucosal fentanyl citrate was shown to be safe and more effective for short-duration episodes of breakthrough pain than immediate-release oral morphine sulfate. Because this was a brief study, the long-term efficacy or differences in outcomes is not known. For patients with breakthrough cancer-related pain, nurses can advocate for those medications that are shown to provide the most rapid-onset reduction in pain intensity. Fentanyl has a relatively short duration of action, so it may be most appropriate for use with the acute onset and short duration of breakthrough pain.