Phase 4
Completed N=84
Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain
Source: ClinicalTrials.gov NCT02459964 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation). — 5.14; 4.90 NRS Pain Intensity Score
◆ Published Evidence
Established
27citations · ~5 / year
Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial.
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.
Linked Publications
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Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation). |
5.14; 4.90 | — |
| SECONDARY Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score |
5; 10 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.)
- Ability and willingness to communicate the intensity of pain using NRS at the frequency dictated by the protocol
Exclusion Criteria
- Patients with a history of chronic active hepatitis, cirrhosis or hepatic encephalopathy
- Inability to give informed consent
- Known or suspected hypersensitivity or intolerance to fentanyl or hydromorphone or excipients in the study medications
- 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.
- 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.
- 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)
- Previous participation in randomization in this trial
- Has taken oral immediate release opioids within 4 hours prior to arrival.
Data sourced from ClinicalTrials.gov (NCT02459964) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.