CTRI/2023/05/052794进行中（未招募）3 期
A multicentre, prospective, randomized, open label, active controlled, clinical trial evaluating the efficacy and safety of Paracetamol 1000 mg/4 ml intravenous bolus injection vs Paracetamol intravenous infusion 1% w/v (100 ml) for the treatment of post-operative pain
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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).
排除标准
- •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.
研究者
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