Trial Outcomes & Findings for Fentanyl for Breakthrough Pain in the Emergency Department (NCT NCT01812759)

Last Updated: 2021-06-29

Results Overview

Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

4 hours

Results posted on

2021-06-29

Participant Flow

Cancer patients presenting to the M. D. Anderson Cancer Center Emergency Department (ED) for treatment of acute breakthrough pain, who met study inclusion criteria.

The first patient's primary physician admitted the patient to the hospital after the patient consented to the study but before the patient received any medication.

Participant milestones

Participant milestones
Measure	Placebo Placebo nasal spray administered in each nostril plus hydromorphone (PCA) Initial Patient Controlled Analgesia. (PCA) loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	Intervention Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	No Medication Patient consented but admitted to hospital before medication administered.
Overall Study STARTED	1	1	1
Overall Study COMPLETED	1	1	0
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo nasal spray administered in each nostril plus hydromorphone (PCA) Initial Patient Controlled Analgesia. (PCA) loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	Intervention Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	No Medication Patient consented but admitted to hospital before medication administered.
Overall Study Physician Decision	0	0	1

Baseline Characteristics

Fentanyl for Breakthrough Pain in the Emergency Department

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 4 hours

Population: One participant consented but admitted to hospital before medication administered

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	Intervention n=1 Participants Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	No Medication Patient consented but admitted to hospital before medication administered.
Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.	1 Participants	1 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Medication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kumar Alagappan,Chair, Emergency Medicine

UT MD Anderson Cancer Center

Phone: (713) 745-9911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=1 Participants Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	Intervention n=1 Participants Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.	No Medication n=1 Participants Patient consented but admitted to hospital before medication administered.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Number of Participants with Pain Score between 7 and 10 using an 11- point (NRS)	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants