Study on Managing Moderate to Severe Limb Trauma Pain in Emergency Patients Using Sublingual Sufentanil Compared to a Drug Combination

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What is this study about?

This clinical trial is focused on managing moderate to severe pain caused by a single injury to the arm or leg. The study will use a medication called sufentanil, which is administered as a sublingual tablet, meaning it is placed under the tongue to dissolve. The purpose of the study is to determine how effective this method is in relieving pain compared to the standard treatments currently used in emergency situations.

Participants in the study will receive sufentanil and their pain levels will be monitored over a period of time. The study will observe changes in pain levels at various intervals, such as 15, 30, 45, 60, 120, and 180 minutes after taking the medication. Additionally, the study will monitor for any side effects, including low blood pressure, slow heart rate, breathing difficulties, sweating, drowsiness, nausea, vomiting, and dizziness. At the end of the study, participants will be asked to rate their satisfaction with the pain management they received.

Other medications involved in the study include ketoprofen, morphine hydrochloride, paracetamol, codeine phosphate hemihydrate, tramadol hydrochloride, nefopam, and a combination of nitrous oxide and oxygen. These medications are part of the standard pain management options and will be used to compare the effectiveness of sufentanil. The study aims to provide valuable insights into the best practices for managing pain in emergency settings.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is an adult with a pain rating of 4 or higher on a numeric scale, has a single trauma to the upper or lower limb, a Glasgow Coma Scale score of 15, and an oxygen saturation level above 95% in ambient air.

2 administration of medication

The main objective is to evaluate the effectiveness of sublingual sufentanil 30 micrograms for managing moderate to severe pain. The medication is administered under the tongue, allowing it to dissolve and enter the bloodstream quickly.

3 pain assessment

Pain levels are measured using a verbal numerical scale at various intervals: initially (T0), then at 15 minutes (T0+15), 30 minutes (T0+30), 45 minutes (T0+45), 60 minutes (T0+60), 120 minutes (T0+120), and 180 minutes (T0+180). The primary focus is on the change in pain rating between T0 and T0+60 minutes.

4 monitoring of side effects

Throughout the trial, any side effects such as low blood pressure, slow heart rate, breathing difficulties, sweating, drowsiness, nausea, vomiting, or dizziness are monitored to assess the medication’s tolerance.

5 hemodynamic monitoring

Vital signs, including blood pressure, pulse, oxygen saturation, and respiratory rate, are regularly checked to ensure patient safety and to observe any changes in response to the medication.

6 patient feedback

At the conclusion of the study period (T0+180 minutes), patients are asked to provide feedback on their experience using a verbal satisfaction scale from 0 (very dissatisfied) to 10 (very satisfied). This includes an evaluation of the medication and overall pain management.

Who Can Join the Study?

The patient must be an adult.
The patient must have a pain level of 4 or higher on a scale where 0 means no pain and 10 means the worst pain possible.
The pain must be from a single injury to either the upper or lower limb, such as an arm or leg.
The patient must have a Glasgow Coma Scale score of 15, which means they are fully alert and oriented.
The patient must have an oxygen saturation level of more than 95% when breathing normal air. This means their blood has enough oxygen.
Both male and female patients can participate.
The study does not include people considered to be in a vulnerable population, which means those who might need special protection or care.

Who Cannot Join the Study?

Patients who have experienced a trauma to the lower or upper limb. Trauma means an injury or damage to the body.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who belong to a vulnerable population. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.12.2024

Trial locations

Investigated drugs:

Sufentanil is a medication used in this trial to manage moderate to severe pain in emergency situations. It is administered under the tongue (sublingually) to provide quick relief for patients who have experienced a single traumatic injury. The trial aims to evaluate how effective this medication is in reducing pain compared to the standard pain management methods used in the emergency department.

Trauma to the lower or upper limb – This condition involves physical injury to the arms or legs, which can result from accidents, falls, or direct impacts. The trauma can cause damage to bones, muscles, tendons, or ligaments, leading to pain, swelling, and limited movement. Depending on the severity, the injury may involve fractures, sprains, or bruises. The affected area may exhibit redness, warmth, and tenderness. Over time, the body initiates a healing process, which may include inflammation and tissue repair. Recovery can vary based on the extent of the injury and the individual’s overall health.

Trial ID:

2024-519217-64-00

Protocol code:

RBHP 2024 MOUSTAFA

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Managing Moderate to Severe Limb Trauma Pain in Emergency Patients Using Sublingual Sufentanil Compared to a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?