Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain
Condition: Advanced Cancers; Pain
Intervention: Fentanyl Nasal Spray; Hydromorphone Hydrochloride; Phone Call
Intervention description: 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); 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).; 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.
Intervention MeSH terms: Fentanyl; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Healthy volunteers: No
Keywords: Advanced Cancers; Pain; Fentanyl nasal spray; Hydromorphone hydrochloride; Phone call; Numeric Rating Scale; NRS

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.
    

Eligibility criteria:

        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.