Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Paracetamol 1000 mg/4 ml intravenous bolus injection (Mfg. by Troikaa Pharmaceuticals Ltd).: Test drug will be given every six hours for 24 hours (total four doses).
Control Interventio
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender in the age group of 18-70 years. 2. Patients with body weight more than 50 kg. 3. Patients scheduled for elective unilateral or bilateral, primary or uncomplicated secondary total replacement of hip or knee or abdominal surgery performed according to the standard technique used in each study site. 4. Patient with physical status I or II, as per American Society of Anaesthesiologists Physical Status Classification (Annexure - I). 5. Patients willing to give written informed consent prior to participation in the study. 6. Patients who require post-operative hospitalization for at least 48 hours. 7. Able to understand the study procedures and the use of the pain scales and to communicate meaningfully with the study observer and staff. 8. Patient requires surgery performed under general, spinal or epidural anaesthesia. 9. Patient free of any contra-indication to the study drugs and the rescue medication. 10. Patient free of other painful physical conditions which might confound quantifying postoperative pain. 11. The female subjects who are of non-childbearing potential (or of childbearing potential, and who have a negative urine pregnancy test at screening). Post-Operative Day 1 Randomization Criterion: Patient having postoperative pain intensity of following scale on the morning of post operation Day 1 1. =40 mm at rest on a 100 mm Visual Analogue Scale (VAS).
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity or contra indication to paracetamol. 2. Patient with known or suspected history of alcohol or drug abuse. 3. Patient with psychiatric disease or medical conditions which in the opinion of the investigator might invalidate patient ability to communicate with the investigator or to comply with the study procedures. 4. Any abdominal laparoscopic surgeries in which bariatric procedures including gastric bypass or gastric banding, exploratory procedures in which no visceral dissection was performed, and procedures with minimal visceral dissection, such as laparoscopic sterilization. 5. Patient scheduled for early re-intervention or re-instrumentation, i.e. within 30 days of the initial procedure or less. 6. Patients with serum creatinine more than 2.5 times of the upper limit of normal value. 7. Patients with elevated liver enzymes (SGOT, SGPT and Total Bilirubin) more than 2 times of the upper limit of normal value. 8. Patient with active hepatic disease, evidence of clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) that suggested the potential for an increased susceptibility to hepatic toxicity with study medication exposure. 9. Respiratory insufficiency or severe cardiac insufficiency not stabilized by therapy. 10. Patients with present history of hypotension or shock. 11. Patients with raised intracranial pressure or convulsions. 12. Patients with present history of peptic ulcers and/or gastrointestinal bleeding. 13. Pregnant and/or lactating women. 14. Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening. 15. Patients, for any reason not considered to be suitable candidate by the investigator. 16. Patient who was taking any concomitant treatments (i.e. sedatives, hypnotics, anxiolytics, anti-depressant drugs, tranquilizers) which could potentially confound the quantification of analgesia. 17. Patient treated with MAO inhibitors or whose treatment with these had been stopped less than 10 days prior to surgery; patient treated with corticosteroids or whose treatment with these had been stopped less than 7 days prior surgery. 18. Patient treated with microsomal enzyme inducers such as barbiturates, isoniazid, anticonvulsants or zidovudine. Postoperative Eligibility Exclusion Criteria: A subject will not be eligible for entry if any of the following criteria will met after surgery: 1. Subject undergoes any surgery other than the planned surgery or had intraoperative or postoperative complications that, in the view of the investigator, made study participation inadvisable. 2. Patient who had taken NSAIDs / any other analgesic drug within 8 hours (48 h for long acting NSAIDs) prior to administration of the study medications. 3. Patient receiving epidural or intrathecal opioids or local anaesthetics for postoperative pain control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity difference on VAS (PIDvas) at 1 hr from baselineTimepoint: 1 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory investigationsTimepoint: baseline and at the end of study.;Number and percentage of patients requiring rescue medication at each time point during the 24 hours after the first doseTimepoint: 5 min, 15 min, 30 min, 45 min, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 18 hr and 24 hr.;Occurrence of injection site phlebitis will be assesses using Visual Infusion Phlebitis scaleTimepoint: 1 hour post each dose.;Pain intensity difference on categorical scale (PIDcat) from baselineTimepoint: 5 min, 15 min, 30 min, 45 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 18 hr and 24 hr.;Pain intensity difference on VAS (PIDvas) from baseline. Timepoint: 5 min, 15 min, 30 min, 45 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 18 hr and 24 hr;Pain on injection site at the time of injectionTimepoint: at each doses (total four dose every six hours over 24 hours);Pain relief (PR) on a five-point verbal scaleTimepoint: 5 min, 15 min, 30 min, 45 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 18 hr and 24 hr.;Patient global evaluation of satisfaction with study treatment (four-point scale)Timepoint: 6 and 24 hrs;Peak pain scores: MAXPID (maximum pain intensity difference from baseline on VAS), MAXPR (maximum pain relief), and MAXPRID (maximum time-specific sum of PIDcat and PR (PRID))Timepoint: over 6 hr;Physical examinationsTimepoint: baseline and at the end of study;Summation of pain scores: TOTPAR (Time-weighted summation of pain relief scores by area under the PR), SPIDvas (Time-weighted summation of pain scores by area under the PIDvas), SPIDcat (Time-weighted summation of pain scores by area under the PIDcat), and SPRID (Time-weighted Sum of Pain Relief (PR) and Pain Intensity Difference (PIDcat)).Timepoint: 5 min, 15 min, 30 min, 45 min, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 18 hr and 24 hr.;Time to first rescue.Timepoint: during the 24 hours after the first dose;Time to peak scores (MAXPID, MAXPR, MAXPRID)Timepoint: over 6 hr;Treatme | — |
Countries
India
Contacts
Public ContactVivek Agarwal
Troikaa Pharmaceuticals Ltd.
Outcome results
None listed