Phase 2
Completed N=46
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil
Healthy
Source: ClinicalTrials.gov NCT04959812 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Tolerance to Simulated Hemorrhage — 599; 651 min*mmHg
Summary
This study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance to Simulated Hemorrhage |
599; 651 | — |
| SECONDARY Pain Assessment |
1.04; 1.16 | — |
Eligibility Criteria
Inclusion Criteria
- 18-45 years of age
- Healthy
- Non-obese (body mass index less than 30 kg/m2)
- Body mass greater than or equal to 65 kg
- Speak English
Exclusion Criteria
- Subjects not in the defined age range
- Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy or breast feeding
- Body mass less than 65 kg
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Subjects who cannot speak or read English
- Positive urine drug screen
- Currently taking pain modifying medication(s)
Data sourced from ClinicalTrials.gov (NCT04959812). 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. Informational only — not medical advice.