Low Dose Dexmedetomidine Versus Ketamine in Multiple Fracture Ribs

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
  • Ketamine (DRUG)
    low dose ketamine infusion 2.5 µ/kg/min for 5 days.
  • 0.9% saline (OTHER)
    the same dose and duration of normal saline will be given for 5 days.

Condition or Disease

  • Rib Fractures

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 90 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Jun 12, 2021 ACTUAL
    Primary Completion: Jul 01, 2024 ESTIMATED
    Completion Date: Jul 25, 2024 ESTIMATED
    Study First Posted: Jun 16, 2021 ACTUAL
    Last Updated: Apr 11, 2023

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • 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 Outcomes

    • 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 Outcomes

    • From complete blood picture, neutrophil/lymphocyte ratio is measured to assess anti-inflammatory properties of the study drugs daily for 3 days.

    More Details

    NCT Number: NCT04928300
    Other IDs: 17300614
    Study URL: https://clinicaltrials.gov/study/NCT04928300
    Last updated: Sep 29, 2023