Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

Phase 3

Recruiting

• Conditions: Rib Fractures
• Interventions: Other: 0.9% saline; Drug: Ketamine; Drug: Dexmedetomidine

• Registration Number: NCT04928300
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study Start: 2021-06-12
• Study First Posted: 2021-06-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	0.9% saline	The same dose and duration of normal saline will be given.
Group K	Ketamine	Ketamine infusion 2.5 µ/kg/min for 5 days.
Group D	Dexmedetomidine	Dexmedetomidine infusion IV for 5 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Assuit, Egypt