Trial Outcomes & Findings for Sublingual Fentanyl and Procedural Burn Pain (NCT NCT02241486)

Results Overview

Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

60 min

Results posted on

2017-07-28

Participant Flow

There are no pre-assignment details.

Participant milestones

Participant milestones
Measure	Sublingual Fentanyl Spray Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sublingual Fentanyl and Procedural Burn Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sublingual Fentanyl Spray n=2 Participants Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: 60 min

Population: No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.

Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Outcome measures

Outcome measures
Measure	Sublingual Fentanyl Spray Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Pain Relief	0

Adverse Events

Sublingual Fentanyl Spray

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

Dr. Joseph R. Holtman

Loyola University Medical Center

Phone: 7082168563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place