Rib Fractures
Conditions
Brief summary
In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine normal saline in patients with multiple fracture ribs on conservative treatment.
Detailed description
A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to two groups (30 subjects each) with traumatic multiple fracture ribs 3 ribs or more. After thoracic epidural is inserted, the drug study intervention will be started and run for 5 days during ICU admission. In (Group D) low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. In (Group C) the same dose and duration of normal saline will be given.
Interventions
DRUGDexmedetomidine
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
OTHER0.9% saline
the same dose and duration of normal saline will be given for 5 days.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonographic diaphragm function | 5 days | Diaphragmatic excursion and thickness will be assessed by ultasound for 5 days with diaphragmatic dysfunction (DD) is diagnosed if diaphragmatic excursion is \<10 mm and diaphragmatic thickness is \<2 mm. . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale for pain | 48 hours | Severity of pain will be assessed and scored by 10-point visual analogue scale (VAS). The patients will be instructed on how to use VAS for the assessment of the degree of pain (with 0 representing no pain and 10 cm representing the worst imaginable pain). According to the degree pain given by the patient, classification of pain severity will be done as follows: no pain = 0, mild pain \<3, moderate pain 4-6 and severe pain \>7. VAS will be recorded at zero time before drug intervention, 4 h, 6 h, 12 h, 24 h and 48 h after the start of the treatment in all groups by the anesthesia resident not involved in any other part of the study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil/lymphocyte ratio (NLR) | 3 days | From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days. |
Countries
Egypt
Contacts
Primary ContactOmar Soliman, MD
Outcome results
None listed