Fentanyl for Breakthrough Pain in the Emergency Department

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to receive either fentanyl nasal spray or a placebo nasal spray. You will have an equal
chance of being assigned to either group.

Neither you nor the study staff will know if you are receiving the study spray or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.

Study Visit and Study Treatment:

During your stay in the Emergency Department today, the following tests and procedures will
be performed:

- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
recorded.

- Information from your medical record about your age, sex, race, status of the disease,
and any drugs that you may be taking for pain.

- The study nurse will also ask you some questions about your pain. It should take about 5
minutes to answer these questions.

You will then begin study treatment with either the fentanyl nasal spray or placebo nasal
spray. The study nurse will help you use the nasal spray.

You will stay in the Emergency Department and will be monitored for up to 8 hours after the
treatment has been administered. During this time, you will be asked about your pain and any
side effects you may be having. The study nurse will also monitor your IV pain drug levels
and other vital signs.

Length of Treatment:

Your active participation in this study will be over after your are monitored for up to 8
hours, at which time you will either be discharged to go home or admitted to the hospital
based on your pain response and any other health problems that may be found during your visit
to the Emergency Department.

Follow-Up Phone Call:

About 24 hours after your participation is over, the study nurse will call you by phone to
ask if you experienced any other side effects since finishing the study treatment. The phone
call should only last about 5 minutes. If you are still an inpatient at the hospital, the
study nurse may visit you and ask you these questions in person.

This is an investigational study. Fentanyl nasal spray is FDA approved and commercially
available for the treatment of pain. It's use to help with cancer pain in the Emergency
Department is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Cancer patients presenting to the Emergency Department for treatment of acute
breakthrough pain who are already receiving and who are tolerant to opioid therapy for
their underlying persistent cancer pain. (Patients considered opioid tolerant are
those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal
fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral
oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.)

2. Patients must have severe pain on an 11-point Numeric Rating Scale (NRS 7-10)

3. Breakthrough cancer pain must be of sufficient severity to warrant the use of
intravenous opioids in the judgment of the treating emergency physician

4. Age between 18 and 75 years

5. Able to understand the description of the study and give informed consent

6. Patients must be willing to and capable of providing frequent pain assessments for up
to 8 hours

7. English-speaking

Exclusion Criteria:

1. Patients will not be approached while they are in acute distress and those exhibiting
symptoms (such as dyspnea, uncontrolled nausea/vomiting or vertigo) to such an extent
that impairs their ability to understand and evaluate informed consent

2. Patients participating in other clinical trials for pain

3. Patients who are not already tolerant to opioids

4. Patients, who in the judgment of the treating clinician, are suspected to have hepatic
or renal failure

5. Patients who are pregnant or lactating

6. Patients with a known allergy or significant reaction to fentanyl, the components of
the IN formulation, hydromorphone, or other opioids

7. Patients already on high morphine equivalent daily dose (MEDDs) (>500 mg/day).