Health Condition 1: K00-K14- Diseases of oral cavity and salivary glands
Conditions
Interventions
Intervention1: Cap Flupirtine: Cap.Flupirtine 100 mg TDS for 1st 48 hours by oral route and then SOS till 7th day by oral route.It is one of the first drug of the class of selective neuronal potassium
Sponsors
Sanjay Gandhi Institute of Trauma and Orthopaedics
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who have given written informed consent to be a part of the study. 2. Patients in the age group between 18 to 65 years, of either sex. 3. Patients of ASA group I and II. 4. Patients planned for Open reduction and internal fixation for treatment of Maxillofacial Trauma. 5. Patients with no history of systemic disorders and any other mental illness.
Exclusion criteria
Exclusion criteria: 1.Patients with severe debilitating conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension, cardio respiratory conditions, previous history of cerebrovascular accidents, myocardial infarction, coronary artery disease, impaired renal and hepatic function. 2.All pregnant and lactating females. 3.Patients on antiplatelet/anticoagulant therapy. 4.Any history of opium addiction. 5.Patients with concomitant head injuries, cervical spine injuries or debilitating thoracic or abdominal trauma. 6.Patient with known allergy to Aceclofenac and Flupirtine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the analgesic efficacy of Flupirtine 100 mg TDS administered orally in Post Operative mandibular Trauma patients.Timepoint: To evaluate the analgesic efficacy of Flupirtine 100 mg TDS administered orally in Post Operative mandibular Trauma patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| pain using NRS scale in both the study groups postoperatively.Timepoint: pain using NRS scale postoperatively at 0,1,2,4,6,8,10,12,24,48,72 hours, 5th and 7th day.;To evaluate and compare time weighted sum pain intensity difference (SPID)Timepoint: at 0,1,2,4,6,8,10,12,24,48 hours.;To calculate and compare total pain relief (TOTPAR) in both study groupsTimepoint: at different time intervals till 48 hours.;preoperative hemodynamic parameters like Pulse rate, Systolic Blood Pressure, Diastolic Blood Pressure with postoperativeTimepoint: at 0,2,4,6,8,10,12 hours with in both the study groups.;pain at function in both the study groups postoperativelyTimepoint: at 0,24,48,72 hours and 7th day;onset of analgesia postoperatively after administration of both the drugs to their respective study groupsTimepoint: after administration ;postoperative complications like nausea, vomiting (with Impact scale) post operative bleeding, abdominal discomfort, dizziness in both the study groups.Timepoint: postoperatively;Liver function test levels (SGPT, SGOT, ALP) postoperativelyTimepoint: postoperatively at 48 hours and on 7th day.;quality of life postoperatively using QHIP-14 questionnaire in both study groups.Timepoint: postoperratively | — |
Countries
India
Contacts
Public ContactDr. Harshitha R
Sanjay Gandhi Institute of Trauma and Orthopedics
Outcome results
None listed