Sufentanil is a strong synthetic opioid analgesic that has been used as an anesthetic agent. Research has evaluated the effects of an intranasal formulation of sufentanil as a treatment for cancer-related breakthrough pain. At the time of this writing, this formulation is not yet FDA-approved for use in the United States. Sufentanil for injection is also available.
Effectiveness Not Established
Research Evidence Summaries
Good, P., Jackson, K., Brumley, D., & Ashby, M. (2009). Intranasal sufentanil for cancer-associated breakthrough pain. Palliative Medicine, 23(1), 54–58.doi: 10.1177/0269216308100249
To demonstrate the efficacy, safety, and acceptability of intranasal sufentanil as a treatment for cancer-related breakthrough pain (BTP)
Intervention Characteristics/Basic Study Process:
Dose titration included three steps. In step 1, a clinician administered 9 mcg sufentanil. Administration was repeated at 10 and 20 minutes, as required. If sufentanil was ineffective at 30 minutes, the clinician administered, the patient's usual BTP opioid. Step 2 comprised actions relating to the next episode of BTP. During this episode, the clinician administered 18 mcg sufentanil, using the same repetition procedure as in step 1. In step 3, during the next episode of BTP, the clinician administered 36 mcg sufentanil, using the same repetition procedure as in step 1. In all steps, pain was assessed at 0, 5, 10, 15, 30, 60, and 120 minutes. In the ongoing phase of the study, in each BTP episode, each patient received the titrated dose that had proven effective.
- The sample was composed of 30 patients. The study comprised 64 BTP episodes.
- Authors did not report information about patients' ages.
- Authors did not report information about the gender of patients.
- The sample comprised patients who had cancer, were not opioid naive, showed clinical evidence of opioid responsiveness, and were taking stable doses of long-acting opioids. The sample included 11 cases of neuropathic pain, 7 of visceral pain, 6 of somaic pain, 5 of mixed pain, and one of pain of an unknown type. No patient died during the study.
- Three palliative care units in Australia
Prospective, descriptive study
- Verbal rating, on a 0–10 scale, of percentage of pain intensity difference (%PID)
- Respiratory rate
- Oxygen saturation
- Presence or absence of nausea, vomiting, confusion, nasal pain, or nasal bleeding
- Drowsiness scale (0 = none, 4 = unarousable)
- Median verbal rating of PID at baseline was 5.5, mean rating was 5.9 (SD = 1.8); median verbal rating of PID at 15 minutes was 3, mean rating was 3.3 (SD = 2.3) (p < 0.0001); median verbal rating of PID at 30 minutes was 2, mean rating was 2.5 (SD = 2.4) (p < 0.0001).
- The %PID was greater than 33% at 30 minutes, by which time 40 of 64 patients (63%) had responded to treatment.
- Dose range was 9–108 mcg. Median dose was 18 mcg.
- Of 30 participants, 23 rated intranasal sufentanil as better than usual medications.
- Four of 64 patients (6%), reverted to usual BTP medication after 30 minutes.
- Authors found no correlation between baseline opioid dose and the dose that was effective in treating BTP.
- In three episodes the drowsiness score was higher than 2. In two patients, the adverse effect was nausea. In one patient, the adverse effect was headache.
The study showed that intranasal sufentanil has rapid onset and is an effective and safe means of controlling cancer-related BTP.
- The study had a small sample, with fewer than 100 patients.
- Authors did not provide a definition of effective pain relief.
- Authors did not provide demographic information.
Sufentanil may be an option for the treatment of BTP; presently, however, its use remains investigational.