Phase 2
N=38
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04136548 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Cumulative Stress Index — 647; 676 mmHg x minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fentanyl (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Stress Index |
647; 676 | — |
| SECONDARY Pressure Pain Tolerance |
1.6; 1.1 | — |
Summary
The purpose of this project is to test how fentanyl, an analgesic currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.
Eligibility Criteria
Inclusion Criteria
- Healthy
- Non-obese (body mass index less than 30 kg/m2)
- Body mass greater than or equal to 65 kg
Exclusion Criteria
- Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy or breast feeding
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Positive urine drug screen
- Currently taking pain modifying medication(s)
Data sourced from ClinicalTrials.gov (NCT04136548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.