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）
- 入组人数
- 504
- 试验地点
- 15
- 主要终点
- Pain intensity difference on VAS (PIDvas) at 1 hr from baseline
研究概览
简要总结
Troikaa Pharmaceuticals Limited has developed 1g in 4 ml (250 mg/ml) formulation of paracetamol, which is proposed to be, administered as slow IV bolus after diluting it in 16 ml of sterile water for injection. Therefore, administration of this formulation over one day will only increase fluid volume by 80 ml and can be administered safely in patient with volume overload. It will be more convenient than the infusion and will also decrease the cost of therapy.
This is 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. Adult patients requiring surgery will be screened (within 14 days of receiving study drug treatment) for eligibility based on screening inclusion and exclusion criteria and they will undergo surgery (Day 0) as per investigator’s surgery (surgical procedure, anaesthesia and analgesia) protocol. On the next day morning of the surgery (Day 1), patient eligible as per post-operative day 1 inclusion/exclusion randomization criterion will be randomised in test and reference arms (1:1) to receive study drug treatments. Patient will receive either four intravenous bolus injections over 2 minutes of test product or intravenous infusion over 15 minutes of reference product every 6 hours for 24 hours. After first dose of study drug administration, patients will be evaluated for pain intensity, pain relief, rescue drug requirement and safety parameters at pre-defined time-points till 24 hours post first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender in the age group of 18-70 years.
- •Patients with body weight more than 50 kg.
- •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.
- •Patient with physical status I or II, as per American Society of Anaesthesiologists Physical Status Classification (Annexure.
- •Patients willing to give written informed consent prior to participation in the study.
- •Patients who require post-operative hospitalization for at least 48 hours.
- •Able to understand the study procedures and the use of the pain scales and to communicate meaningfully with the study observer and staff.
- •Patient requires surgery performed under general, spinal or epidural anaesthesia.
- •Patient free of any contra-indication to the study drugs and the rescue medication.
- •Patient free of other painful physical conditions which might confound quantifying postoperative pain.
- •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
- •â‰¥40 mm at rest on a 100 mm Visual Analogue Scale (VAS).
排除标准
- •Patients with known hypersensitivity or contra indication to paracetamol.
- •Patient with known or suspected history of alcohol or drug abuse.
- •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.
- •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.
- •Patient scheduled for early re-intervention or re-instrumentation, i.e. within 30 days of the initial procedure or less.
- •Patients with serum creatinine more than 2.5 times of the upper limit of normal value.
- •Patients with elevated liver enzymes (SGOT, SGPT and Total Bilirubin) more than 2 times of the upper limit of normal value.
- •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.
- •Respiratory insufficiency or severe cardiac insufficiency not stabilized by therapy.
- •Patients with present history of hypotension or shock.
- •Patients with raised intracranial pressure or convulsions.
- •Patients with present history of peptic ulcers and/or gastrointestinal bleeding.
- •Pregnant and/or lactating women.
- •Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening.
- •Patient who was taking any concomitant treatments (i.e. sedatives, hypnotics, anxiolytics, anti-depressant drugs, tranquilizers) which could potentially confound the quantification of analgesia.
- •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.
- •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:
- •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.
- •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.
- •Patient receiving epidural or intrathecal opioids or local anaesthetics for postoperative pain control.
结局指标
主要结局
Pain intensity difference on VAS (PIDvas) at 1 hr from baseline
时间窗: 1 hr
次要结局
- Pain intensity difference on categorical scale (PIDcat) from baseline(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.
- 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)).(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.)
- Number and percentage of patients requiring rescue medication at each time point during the 24 hours after the first dose(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.(during the 24 hours after the first dose)
- Pain relief (PR) on a five-point verbal scale(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.)
- 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))(over 6 hr)
- Vital signs(baseline, one hour after each dose and at 24-hour post first dose)
- Physical examinations(baseline and at the end of study)
- Treatment emergent adverse events(up to 24 hours)
- Time to peak scores (MAXPID, MAXPR, MAXPRID)(over 6 hr)
- Patient global evaluation of satisfaction with study treatment (four-point scale)(6 and 24 hrs)
- Occurrence of injection site phlebitis will be assesses using Visual Infusion Phlebitis scale(1 hour post each dose.)
- Pain on injection site at the time of injection(at each doses (total four dose every six hours over 24 hours))
- Laboratory investigations(baseline and at the end of study.)
研究者
研究点 (15)
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