Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain

Study Groups and Drug Administration:

If participant agrees to take part in this study, they will be randomly assigned (as in the
flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group
is better, the same, or worse than the other group. Participant will have an equal chance of
being in either group:

- If participant is in Group 1, they will receive the fentanyl nasal spray. The study
staff will help participant use the nasal spray.

- If participant is in Group 2, the emergency center nurse will give them the
hydromorphone hydrochloride by vein.

Study Procedures:

Participant will stay in the emergency department for at least 4 hours and will be monitored
after receiving fentanyl or hydromorphone hydrochloride. During this time, participant will
be asked about their pain and any side effects they may be having every 15 minutes for 2
hours and then every 30 minutes for another 2 hours. The study staff will also monitor
participant's vital signs, and ask them a few more questions at the end of the study.

Length of Study Participation:

Although participant will stay in the emergency department for at least 4 hours, the average
length of stay for participants with severe pain is about 9 hours. When participant is
discharged from the emergency department or admitted to the hospital, their active
participation in the study is over.

Follow-Up Phone Call:

About 24 hours after patient's active participation is over, the study nurse will call them
to ask if they had any other side effects since taking part in the study. The phone call
should last about 5 minutes. If participant is still an inpatient at the hospital, the study
nurse may visit them and ask them these questions in person.

This is an investigational study. Hydromorphone hydrochloride is FDA approved and
commercially available for the treatment of pain. Fentanyl nasal spray is FDA approved and
commercially available for the treatment of pain. Its use to help with cancer pain in the
emergency department is investigational.

Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Cancer patients with severe pain (i.e., >=7 on NRS, see Table 1) already on opioid
therapy for one week or longer, at least 60 mg of oral morphine/day, 25 mcg of
transdermal fentanyl/hour, 30 mg of oxycodone/day, 8 mg oral hydromorphone/day, 25 mg
oral oxymorphone/day, or an equianalgesic dose of another opioid.

2. Ability to give informed consent before any trial-related activities (Trial-related
activities are any procedure that would not have been performed during normal
management of the subject.)

3. Ability and willingness to communicate the intensity of pain using NRS at the
frequency dictated by the protocol

Exclusion Criteria:

1. Patients with a history of chronic active hepatitis, cirrhosis or hepatic
encephalopathy

2. Inability to give informed consent

3. Known or suspected hypersensitivity or intolerance to fentanyl or hydromorphone or
excipients in the study medications

4. Patients with sinusitis, obstruction of nasal passages, nasopharyngeal cancer,
paranasal sinus malignancies, or any conditions in the nasopharyngeal anatomical area
that may affect the absorption of fentanyl nasal spray.

5. Females who are pregnant, breast-feeding or intending to become pregnant. This
exclusion criterion will be assessed by questioning the patient about the pregnancy
status, breast-feeding status, the intent to become pregnant, the menopausal status,
and the date of the last menstrual period.

6. Females of child-bearing potential, who are not using adequate contraceptive measures
(including condoms, birth control pills, intrauterine devices, contraceptive implants,
or other US FDA-approved contraceptives)

7. Previous participation in randomization in this trial

8. Has taken oral immediate release opioids within 4 hours prior to arrival.