Fentanyl for Breakthrough Pain in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Intervention: Fentanyl Nasal Spray; Hydromorphone PCA; Placebo Nasal Spray
Intervention description: 100 mcg nasal spray administered in each nostril.; 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.; 1 placebo nasal spray administered in each nostril.
Intervention MeSH terms: Fentanyl; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pain; Breakthrough cancer pain; Emergency Department; ED; Fentanyl nasal spray; Lazanda; Placebo nasal spray; Hydromorphone PCA; Dilaudid

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.
    

Eligibility criteria:

        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).