Intranasal sufentanil for treating acute post-traumatic pain in emergency patients
The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.
This study is testing if a nasal spray of sufentanil can help people with severe pain after an injury feel better compared to just the usual pain treatment they receive in the emergency room.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre Academic / other |
| Locations | 1 site (Bruxelles) |
| Trial ID | NCT04137198 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intranasal sufentanil in patients who arrive at the emergency department with acute post-traumatic pain rated 7 or higher on a visual analog scale. Participants are randomly assigned to either a control group receiving standard analgesic treatment or an intervention group receiving standard treatment plus intranasal sufentanil. Pain levels are assessed at 15-20 minutes and 60 minutes post-administration, along with monitoring for any adverse effects and vital signs. The goal is to determine if intranasal sufentanil provides superior pain relief compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are adults presenting with acute post-traumatic pain lasting less than 24 hours and rated 7 or higher on the pain scale.
Not a fit: Patients who may not benefit include those with chronic pain conditions, significant comorbidities, or contraindications to opioid use.
Why it matters
Potential benefit: If successful, this approach could offer a more effective and rapid pain relief option for patients experiencing acute post-traumatic pain in emergency settings.
How similar studies have performed: Other studies have shown promising results with intranasal opioids for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more Exclusion Criteria: * pregnant * \<18 years * prisoners * lesions of head, face or abdomen * no consent given or possible * pain not scorable * known drug abuse or substitution therapy * chronic level 3 pain medication * intake of level 3 \< 8 hours * intoxicated patient * allergy or intolerance to opiates * renal or hepatic insufficiency * \< 50kg body weight * hemodynamic instability
Where this trial is running
Bruxelles
- CHU Saint Pierre — Bruxelles, Belgium (Recruiting)
Study contacts
- Study coordinator: Bernard Kreps, MD
- Email: bernard_kreps@stpierre-bru.be
- Phone: +3225353495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.