Pain | Fentanyl for Breakthrough Pain in the Emergency Department
Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Fentanyl Nasal Spray100 mcg nasal spray administered in each nostril.
Drug:Hydromorphone PCAInitial 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.
Other:Placebo Nasal Spray1 placebo nasal spray administered in each nostril.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Fentanyl Nasal Spray + Hydromorphone PCAFentanyl 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.
Placebo Nasal Spray + Hydromorphone PCAPlacebo 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.
Start Date: January 10, 2014
Completed Date: October 22, 2014
Phase: Phase 4
Primary Outcome: Total Pain Relief Score
Study sponsors, principal investigator, and references
Principal Investigator: Knox H. Todd, MD
Lead Sponsor: M.D. Anderson Cancer Center
Collaborator: Archimedes Pharma US, Inc.