Phase 2
N=44
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04138615 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Tolerance to Simulated Hemorrhage — 385; 692 CSI: Cumulative Stress Index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Morphine (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance to Simulated Hemorrhage |
385; 692 | — |
| SECONDARY Pain Assessment - Algometer |
1.1; 0.9 | — |
Summary
We are examining how morphine (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in our research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.
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 (NCT04138615). 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.