NCT02459964

Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain

A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to compare fentanyl nasal spray with a standard drug given by vein (hydromorphone hydrochloride) to help reduce pain related to cancer in patients coming to the emergency department.

Detailed description

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.

Conditions

• Advanced Cancers
• Pain

Interventions

Type	Name	Description
DRUG	Fentanyl Nasal Spray	Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h)
DRUG	Hydromorphone Hydrochloride	Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
BEHAVIORAL	Phone Call	Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study. The phone call should last about 5 minutes.

Timeline

• Start date: 2015-09-14
• Primary completion: 2020-06-21
• Completion: 2020-06-21
• First posted: 2015-06-02
• Last updated: 2021-06-16
• Results posted: 2021-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study