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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519217-64-00 | EU Trial (CTIS) Number |
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Pain is a common reason for emergency department (ED) visits. However, studies suggest that emergency physicians may not always provide optimal analgesic treatment due to various factors, such as time constraints, demographic factors like gender and age, and concerns about opioid use. As a result, patients with moderate to severe pain often experience long delays before receiving analgesia and may even be discharged with unresolved pain or suboptimal treatment. Additionally, diagnostic procedures for patients with isolated trauma (e.g., clinical examinations, radiographs) can lead to variations in pain levels, making it difficult to assess the effectiveness of analgesia.
A commonly used treatment for moderate to severe pain is intravenous opioid administration. However, this approach requires longer wait times, complex titration, and significant resources (beds, nurses, equipment), which may be limited during peak hours. While oral opioids require fewer resources, their delayed onset and limited titratability restrict their use for severe pain.
The sublingual sufentanil tablet (30 mcg), delivered via a single-dose applicator, was developed for patients with moderate to severe pain in emergency or outpatient surgical settings. Its unique pharmacokinetic and pharmacodynamic properties could offer advantages in non-invasive acute pain management.
Sublingual sufentanil received market authorization in June 2018 for the treatment of moderate to severe acute pain in adults and is already used in many hospitals. However, further studies are needed to confirm its effectiveness and potential superiority in pain management.
The objective of this study is to evaluate the effectiveness of 30 mcg sublingual sufentanil in patients admitted for moderate to severe pain due to isolated trauma. This will be compared to the standard pain management protocol used in the Clermont-Ferrand emergency department, focusing on pain score variations using a numerical rating scale (0-10)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Patient randomized to the "standard of care" arm will receive analgesic treatment according to the department's internal pain management protocol. |
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| SST 30 mcg | Experimental | Patients randomized to the "SST 30 mcg" arm will receive a 30-microgram sublingual sufentanil tablet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sufentanil sublingual 30 mcg tablet | Drug | patient randomized in the "SST 30mcg" arm will receive a 30-microgram sublingual sufentanil tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the effectiveness of sublingual sufentanil compared to the standard analgesic protocol used in the department, by measuring pain scores on the Numerical Rating Scale from 0 to 10 at Hour 0 and Hour 0 +60 minutes | the efficacy of sublingual sufentanil will be measured by the difference in pain scores measured by the NRS between baseline and 60 minutes after receiving treatment NRS is a 10-point scale where 0 means no pain and 10 means the most pain | Hour 0 ; Hour 0 + 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between randomization groups of potential adverse effects. | Safety outcomes : The comparison between randomization groups of potential adverse effects: hypotension, bradycardia, respiratory depression, sweating, drowsiness, nausea and/or vomiting, dizziness. | Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Farès MOUSTAFA, PR | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand, Clermont-Ferrand | Recruiting | France | France |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Standard of Care (SOC) | Other | patients randomized in the "SOC" arm will receive analgesic treatment according to the department's internal pain management protocol. |
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| Pain variation assessed at different time points. | Pain variation assessed in both groups at different time points of the study. Pain will be evaluated using the NRS, à 10-point scale, where 0 corresponds to no pain and 10 to the most intense pain. | Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes |
| Blood pressure variations | Blood pressure variation in patients at different time points, measured using an automatic sphygmomanometer. | Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes |
| Heart rate variations | Heart rate variation in patients at different time points, measured using a heart rate monitor. | Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes |
| Oxygen saturation variation | Oxygen saturation variation in patients at different time points, measured using a pulse oximeter. | Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes |
| Breath frequency variations | variation of breath frequency measured at differents time points | Hour 0 ; Hour 0 + 15 minutes; Hour 0 + 30 minutes; Hour 0 + 45 minutes; Hour 0 + 60 minutes; Hour 0 +120 minutes; Hour 0 + 180 minutes |
| Assessment of patient satisfaction with pain management using a 10-point scale | Assessment of patient satisfaction with pain management using a 10-point scale, where 0 represents "very dissatisfied" and 10 represents "very satisfied." | Hour 0 + 180 minutes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |