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Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

Primary Purpose

Rib Fractures

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
0.9% saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group D

Group K

Group C

Arm Description

Dexmedetomidine infusion IV for 5 days.

Ketamine infusion 2.5 µ/kg/min for 5 days.

The same dose and duration of normal saline will be given.

Outcomes

Primary Outcome Measures

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. .

Secondary Outcome Measures

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.

Full Information

First Posted
June 10, 2021
Last Updated
April 11, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04928300
Brief Title
Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs
Official Title
Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group D
Arm Type
Experimental
Arm Description
Dexmedetomidine infusion IV for 5 days.
Arm Title
Group K
Arm Type
Experimental
Arm Description
Ketamine infusion 2.5 µ/kg/min for 5 days.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
The same dose and duration of normal saline will be given.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
low dose ketamine infusion 2.5 µ/kg/min for 5 days.
Intervention Type
Other
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
Normal saline
Intervention Description
the same dose and duration of normal saline will be given for 5 days.
Primary Outcome Measure Information:
Title
Ultrasonographic diaphragm function
Description
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. .
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Visual analogue scale for pain
Description
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.
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Neutrophil/lymphocyte ratio (NLR)
Description
From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Soliman, MD
Phone
01101266040
Email
omarmakram347@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Soliman
Phone
01101266040
Email
omarmakram347@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28372691
Citation
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.
Results Reference
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Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

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