NCT04641338已完成3 期
Randomized, Multicentre, Superiority Clinical Trial to Assess the Combination of Fixed Dosage Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Pain After Open Pelvic-abdominal Surgery
Brazilian Clinical Research Institute3 个研究点 分布在 1 个国家目标入组 491 人开始时间: 2023年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 491
- 试验地点
- 3
- 主要终点
- Average of sum of the pain difference
研究概览
简要总结
Phase III clinical trial, multicentre, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).
详细描述
The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 years or older;
- •Be able to sign the ICF approved by the IEC and to perform and understand all the study procedures and instructions;
- •Show post-anesthesia recovery with a score greater than or equal to 8 on the modified Aldrete and Kroulik Scale;
- •Experience pain intensity according to the visual analogue scale (VAS) of 3.0 to 10 cm (moderate to severe pain) immediately after surgery;
- •Have an elective open abdominal-pelvic surgery scheduled, not due to malignant neoplasm, to be performed within 4 weeks of screening;
- •Estimated hospital stay for at least 48 hours after the procedure.
排除标准
- •Surgical complications during participant enrollment in the research;
- •Surgery with indication for treatment of confirmed or suspected malignant neoplasm;
- •Chronic use of any non-steroidal anti-inflammatory drugs;
- •Suspected paralytic ileus or intestinal obstruction;
- •Inability to use oral drugs postoperatively;
- •Videolaparoscopic surgery;
- •History of chronic and current use of opioids or other analgesics;
- •Use of concomitant modalities of intravenous or neuraxial analgesia (spinal and epidural) with placement of an epidural catheter for use in the postoperative period, or regional blockade, where the expected duration of analgesia administered intravenously or neuroaxially is maintained after 24 hours of the surgical procedure or randomization, whichever occurs first;
- •Use of immunosuppressive therapy in the last 24 hours prior to surgery;
- •Participants with uncontrollable vomiting present in the postoperative period;
- •Abusive user of alcohol or illicit drugs;
- •Use of drugs with potential interaction with the study drugs;
- •Allergy, hypersensitivity, or known contraindication to the use of ingredients of the study drug;
- •Psychiatric or social disorders that prevent the appropriate compliance with the protocol;
- •Demonstrate inability to understand and perform current pain assessments in the study;
- •Women who are pregnant, breastfeeding, planning to become pregnant, or who have a positive urine pregnancy test.
- •Participants who test positive for COVID-19 (upon presentation of the test report at the time of screening or prior to randomization);
- •Participation in another clinical trial within less than one year (unless the participation is warranted by the principal investigator);
- •Presence of decompensated diabetes mellitus;
- •History of decompensated obstructive or restrictive respiratory disease;
- •Current symptoms or past history of gastrointestinal bleeding;
- •History of blood dyscrasia or chronic disease of any nature that contraindicates the participant's participation at the investigator's discretion;
- •Inability to understand and perform the pain assessments during the study;
- •Hypersensitivity or contraindication to the use of ingredients of the study drugs;
- •Grade III obesity (BMI above 40);
- •Presence of one or more flu-like symptoms, such as: fever, cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 14 days prior to the screening or randomization visit;
- •Other serious comorbidities at the investigators' discretion (such as history of renal, hepatic, cardiac or other peptic ulcer);
- •Any clinical condition that the investigator considers to pose a risk to the patient or interfere with study conduction.
结局指标
主要结局
Average of sum of the pain difference
时间窗: During hospitalization (around 48 hours post surgical procedure)
The primary endpoint of the study is the average sum of the pain difference after study medication compared to the baseline by visual analogic scale from 0 to 10 cm, where 0 = no pain, and 10 = the worst imaginable pain)
次要结局
- Average of visual analogic scale score(During hospitalization (around 48 hours post surgical procedure))
- VRS (verbal scale and relief assessment pain)(During hospitalization (around 48 hours post surgical procedure))
- Assessment of complete pain relief by verbal scale and relief assessment pain (VRS)(During hospitalization (around 48 hours post surgical procedure))
- Need for medication of rescue(During hospitalization (around 48 hours post surgical procedure))
- Assessment of satisfaction with treatment by the participant(14 days)
- Presence of adverse events(14 days)
研究者
研究点 (3)
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