Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928300
• Other study ID #: 17300614
• Status: Recruiting
• Phase: Phase 3
• Start date: June 12, 2021
• Est. completion date: July 25, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Omar Soliman, MD
• Phone: 01101266040
• Email: omarmakram347[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 25, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

Drug:
• Dexmedetomidine
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
• Ketamine
low dose ketamine infusion 2.5 µ/kg/min for 5 days.

Other:
• 0.9% saline
the same dose and duration of normal saline will be given for 5 days.

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Bossolasco M, Bernardi E, Fenoglio LM. Continuous serratus plane block in a patient with multiple rib fractures. J Clin Anesth. 2017 May;38:85-86. doi: 10.1016/j.jclinane.2016.12.015. Epub 2017 Jan 30. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neutrophil/lymphocyte ratio (NLR)	From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days.	3 days
Primary	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	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