Clinical trial · Interventional
Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain
A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting
NCT02459964CI-TRIAL-00052308completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl Nasal Spray | Drug | — | UNRESOLVED |
| Hydromorphone Hydrochloride | Drug | — | UNRESOLVED |
| Phone Call | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fentanyl Nasal Spray
- 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). Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study.
- interventionNames
- Drug: Fentanyl Nasal Spray
- Behavioral: Phone Call
- type
- ACTIVE_COMPARATOR
- label
- Hydromorphone Hydrochloride
- description
- 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.
- interventionNames
- Drug: Hydromorphone Hydrochloride
- Behavioral: Phone Call
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBanala SR, Khattab OK, Page VD, Warneke CL, Todd KH, Yeung SJ. 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. PLoS One. 2020 Jul 10;15(7):e0235461. doi: 10.1371/journal.pone.0235461. eCollection 2020. PMID 32649717