Health Condition 1: G891- Acute pain, not elsewhere classified
Conditions
Interventions
Intervention1: Etodolac injection 400 mg/2ml: Number of Etodolac injections 400 mg/2 ml via intravenous route required within 24 hours. Patient will be given minimum 1 injection or maximum 2 injection
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female patients aged between 18 and 65 years. 2) Patients undergoing open reduction and internal fixation of long bone fracture surgery. 3) Patients with the post operative orthopedic pain of at least 5 cm on the 10 cm pain intensity VAS and at least a score if 2 on 4 point VRS 4) Patients fulfilling the American Society of Anesthesiology (ASA) physical status classification of Class I and Class II 5) Patients able to understand and willing to fully comply with study procedures and restrictions 6) Patients ready to give informed consent, as per applicable regulatory requirements, for participation in the study.
Exclusion criteria
Exclusion criteria: 1) Patients who are unable to remain at the hospital for the duration of the study. 2) Patients having complication during or after surgical procedure. 3) Patients with systemic infection before the surgery is performed 4) Patients with abnormal renal function (Serum Cr >1.5 mg/dL) 5) Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase more than 2.5 times the upper limit of normal values) 6) Patients with known history of HIV 1 or HIV 2, Hepatitis B or C viruses or syphilis infection or malignancy 7) Patients with dementia, other cognitive impairment prohibiting informed consent. 8) Patients with any other clinically significant abnormality(ies) interfering with assessment of disease under evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of intramuscular injection of Etodolac based on the incidence of adverse events (clinical and laboratory) in the treatment of post operative orthopedic pain.Timepoint: Within 24 hrs from 1st dose of study drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the efficacy of Etodolac injection by evaluating changes in pain intensity score using verbal rating scale, visual analogue scale, pain relief score assessed on Likert scale. 2. To evaluate the number of patients who required rescue medication and enumerate the total doses of rescue medication administered. 3. To evaluate patientâ??s and investigatorâ??s global efficacy assessment using five points Likert scaleTimepoint: 1.At 24 hour after first dose of study drug administration. 2. Within 24 hours from first dose of study drug administration 3. After 24 hours from first dose of study drug administration. | — |
Countries
India
Contacts
Public ContactDr Ravi Mehta
Ipca Laboratories Ltd.
Outcome results
None listed