Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

Study Overview
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Brief Summary
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In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine and ketamine in patients with multiple fracture ribs on conservative treatment.

Detailed Description
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A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to three 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 K) low dose ketamine infusion 2.5 µ/kg/min for 5 days. In (Group C) the same dose and duration of normal saline will be given.

Official Title
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Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment

Conditions
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Rib Fractures

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ketamine
* Other: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D<br>Dexmedetomidine infusion IV for 5 days. | Drug: Dexmedetomidine<br>* low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.<br>* Other names: Precedex;|
| Experimental: Group K<br>Ketamine infusion 2.5 µ/kg/min for 5 days. | Drug: Ketamine<br>* low dose ketamine infusion 2.5 µ/kg/min for 5 days.<br>* Other names: ketalar;|
| Placebo Comparator: Group C<br>The same dose and duration of normal saline will be given. | Other: 0.9% saline<br>* the same dose and duration of normal saline will be given for 5 days.<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic diaphragm function | 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. . | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale for pain | 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. | 48 hours |