Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT01812759
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01812759
Study Brief:
Protocol Section:
NCT01812759