Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 176
Inclusion Criteria
- Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
- Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
- Has a pain score within protocol-specified parameters
- Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
- Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
- Has a pain score within protocol-specified parameters
Exclusion Criteria
- Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
- Has planned or recent drug use outside protocol-specified parameters
- Has allergy to fentanyl or morphine
- ...
- Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
- Has planned or recent drug use outside protocol-specified parameters
- Has allergy to fentanyl or morphine
- Has oxygen-dependent conditions or oxygen saturation <95%
Summary
- Conditions
- Acute Pain
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Inclusion Criteria
- Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
- Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
- Has a pain score within protocol-specified parameters
- Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
- Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
- Has a pain score within protocol-specified parameters
Exclusion Criteria
- Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
- Has planned or recent drug use outside protocol-specified parameters
- Has allergy to fentanyl or morphine
- ...
- Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
- Has planned or recent drug use outside protocol-specified parameters
- Has allergy to fentanyl or morphine
- Has oxygen-dependent conditions or oxygen saturation <95%
Tracking Information
- NCT #
- NCT02137525
- Collaborators
- Not Provided
- Investigators
- Study Director: Giovanni DeCastro INSYS Therapeutics Inc
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