Clinical trial NCT01812759
Conditions: Pain
Keywords: Pain Breakthrough cancer pain Emergency Department ED Fentanyl nasal spray Lazanda Placebo nasal spray Hydromorphone PCA Dilaudid
Sponsor: M.D. Anderson Cancer Center
Start date: 2014-01-10; Completion date: 2014-10-22
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department.

In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect.

You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.

Detailed description:
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.

Arms: arm 1: Fentanyl 100 mcg nasal spray administered plus hydromorphone PCA. All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg. arm 2: Placebo nasal spray administered plus hydromorphone PCA . All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.
Interventions: intervention 1: Fentanyl Nasal Spray intervention 2: Hydromorphone PCA intervention 3: Placebo Nasal Spray
Intervention descriptions: intervention 1: 100 mcg nasal spray administered in each nostril. intervention 2: Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg. intervention 3: 1 placebo nasal spray administered in each nostril.

Protocol documents: