Comparing low dose dexmedetomidine and ketamine for pain management in patients with multiple rib fractures
Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
This study is testing whether low dose dexmedetomidine or ketamine works better for managing pain in patients with multiple rib fractures while they are in the ICU.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit) |
| Trial ID | NCT04928300 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of low dose dexmedetomidine versus ketamine in managing pain and assessing diaphragmatic function in patients with multiple rib fractures undergoing conservative treatment. Participants will be randomly assigned to receive either dexmedetomidine, ketamine, or a placebo saline infusion over a five-day period during their ICU stay. The study aims to determine which medication provides better pain relief and anti-inflammatory effects in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with traumatic multiple rib fractures and significant pain despite traditional therapies.
Not a fit: Patients with severe head trauma, multiple traumas, or contraindications to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients with multiple rib fractures.
How similar studies have performed: Other studies have explored the use of dexmedetomidine and ketamine for pain management, but this specific comparison in rib fractures is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (age 18-65 years) of American Society of Anaesthesiologists (ASA) physical status I-II * Traumatic multiple fracture ribs 3 ribs or more, who will be subjected to thorough assessments including chest 3D-CT * Undergoing conservative treatment (chest strappings) * Intractable pain with visual analogue scale (VAS) over 6 after traditional therapies * Glasgow Coma Scale (GCS) ≥ 13. Exclusion Criteria: * Multiple traumas to body parts other than chest with an abbreviated injury scale over 3 * Serious head trauma with a Glasgow coma scale lower than 13 * Mechanically ventilated patients * Massive hemothorax * Injury to the trachea or bronchus with requirement for immediate surgery * Dementia * Use of corticosteroids during ICU stay * Sepsis * Continued use of neuromuscular blocking agents and aminoglycosides antibiotic use as they are known risk factors for ICU-acquired weakness and any known hypersensitivity * Contraindication to the study drugs.
Where this trial is running
Asyut, Assuit
- Assiut university hospital — Asyut, Assuit, Egypt (Recruiting)
Study contacts
- Study coordinator: Omar Soliman, MD
- Email: omarmakram347@yahoo.com
- Phone: 01101266040
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.