Health TrialsbyHealthPanel

Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs

ConditionRib Fractures
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.

  • 0.9% saline

    Other intervention

    the same dose and duration of normal saline will be given for 5 days.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group DExperimental treatment 1 intervention
Group B: Group CPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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. .

Time frame
5 days

Secondary outcomes

1

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.

Time frame
48 hours

Other outcomes

1

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.

Time frame
3 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov
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