A Phase 4 interventional study of Fentanyl Nasal Spray and Hydromorphone Hydrochloride in Advanced Cancers and Pain, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-06-16.
Sponsored by M.D. Anderson Cancer Center · Phase 4, Interventional, and Supportive care
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.
Study Groups and Drug Administration:
If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group:
Study Procedures:
Participant will stay in the emergency department for at least 4 hours and will be monitored after receiving fentanyl or hydromorphone hydrochloride. During this time, participant will be asked about their pain and any side effects they may be having every 15 minutes for 2 hours and then every 30 minutes for another 2 hours. The study staff will also monitor participant's vital signs, and ask them a few more questions at the end of the study.
Length of Study Participation:
Although participant will stay in the emergency department for at least 4 hours, the average length of stay for participants with severe pain is about 9 hours. When participant is discharged from the emergency department or admitted to the hospital, their active participation in the study is over.
Follow-Up Phone Call:
About 24 hours after patient's active participation is over, the study nurse will call them to ask if they had any other side effects since taking part in the study. The phone call should last about 5 minutes. If participant is still an inpatient at the hospital, the study nurse may visit them and ask them these questions in person.
This is an investigational study. Hydromorphone hydrochloride is FDA approved and commercially available for the treatment of pain. Fentanyl nasal spray is FDA approved and commercially available for the treatment of pain. Its use to help with cancer pain in the emergency department is investigational.
Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Fentanyl Nasal Spray · Behavioral: Phone Call
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.
Drug: Hydromorphone Hydrochloride · Behavioral: Phone Call
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)
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. The phone call should last about 5 minutes.
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).
The median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms.
Time frame: Baseline, One hour post time of drug delivery/treatment initiation
Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score
Change in NRS pain intensity scores from randomization to one hour after treatment start based on the percentage of participants with severe pain, NRS score = 7-10, one hour after treatment start for both treatment arms. Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain).
Time frame: One (1) hour after treatment start.
Cancer patients presenting to the M. D. Anderson Cancer Center Emergency Department for treatment of acute breakthrough pain, who met study inclusion criteria.
| Milestone | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered |
|---|---|---|---|
| Started | 42 | 40 | 2 |
| Completed | 42 | 40 | 0 |
| Not completed | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Abnormal ekg changes | 0 | 0 | 1 |
The median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms.
| NRS Pain Intensity Score | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) |
|---|---|---|
| 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 ± 2.16 | 4.90 ± 2.31 |
Change in NRS pain intensity scores from randomization to one hour after treatment start based on the percentage of participants with severe pain, NRS score = 7-10, one hour after treatment start for both treatment arms. Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain).
| Participants | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) |
|---|---|---|
| Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score | 5 | 10 |
Collected over Within 24 hours after ED discharge or hospital admission. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm 1 (Intranasal Fentanyl) | 0/42 (0%) | 0/42 (0%) | 1/42 (2.4%) |
| Treatment Arm 2 (Intravenous Hydromorphone) | 0/40 (0%) | 0/40 (0%) | 3/40 (7.5%) |
| No Medication Administered | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered |
|---|---|---|---|
| HeadacheNervous system disorders | 1/42 | 3/40 | 0/2 |
| FatigueGeneral disorders | 0/42 | 2/40 | 0/2 |
| NauseaGastrointestinal disorders | 0/42 | 1/40 | 0/2 |
| Age, Categorical(Participants) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 39 | 2 | 76 |
| >=65 years | 7 | 1 | 0 | 8 |
| Age, Continuous(years) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| Mean | 54.21 ± 14.452 | 50.33 ± 11.669 | 46 ± 1.000 | 52.32 ± 13.233 |
| Sex: Female, Male(Participants) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| Female | 23 | 23 | 1 | 47 |
| Male | 19 | 17 | 1 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| Hispanic or Latino | 11 | 6 | 0 | 17 |
| Not Hispanic or Latino | 31 | 34 | 2 | 67 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 2 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 3 | 1 | 14 |
| White | 31 | 35 | 1 | 67 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| United States | 42 | 40 | 2 | 84 |
| Baseline NRS Pain Intensity(NRS Pain Score) | Treatment Arm 1 (Intranasal Fentanyl) | Treatment Arm 2 (Intravenous Hydromorphone) | No Medication Administered | Total |
|---|---|---|---|---|
| Mean | 8.69 ± 1.093 | 8.95 ± 1.108 | NA ± NA | 8.82 ± 1.101 |
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M.D. Anderson Cancer Center