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临床试验/NCT03222518
NCT03222518已完成3 期

NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management

University of Monastir1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,500
试验地点
1
主要终点
new oral analgesic medications needed rate

研究概览

简要总结

The purpose of this study is to:

Compare the effect of paracetamol alone against NSAIDs alone against the association of paracetamol + NSAIDs in the treatment of traumatic pain.

详细描述

Paracetamol, NSAIDs, or a combination of the two molecules are usually prescribed. Patients even use these medications without a prescription. It is not known, however, whether or not NSAIDs have an additional value relative to paracetamol for the treatment of pain.

All patients were assigned in a 1:1:1 ratio. Randomization of subjects was performed centrally according to a computer-generated random code provided by one of investigators who was not involved in any other part of the trial. The patients included were divided into 3 groups: Paracetamol group who received paracetamol 1000 mg orally every 8th hour for 7 days; NSAID group who received piroxicam 20 mg orally twice a day for 7 days, and Paracetamol-NSAID combination who received both treatments at the same doses for 7 days. All protocol treatments were administered in opaque packets with code number according to the randomization list by an independent nurse who was not involved in monitoring or follow-up of the individuals. Data were collected for each patient, including demographics, medical history, and findings of the clinical examination. Injury Severity Score (ISS) whose values range from 0 to 75 was also assessed. Each patient was re-evaluated on the 3rd and 7th day post-trauma (D7) using a telephone contact by a clinical research associates who was blinded to the details of the study to note the following clinical data: pain VNS, ED readmissions for residual pain, need for other analgesics other than those of the protocol, other treatment modalities the patient might have used (adherence to the treatment prescribed), and side effects. In addition patients were asked about their satisfaction with pain control following ED using five point Likert scale: very dissatisfied, not satisfied, neutral, satisfied and very satisfied and about the degree to which they adhered to medication schedule. The principal investigator who was aware of the allocation was not involved in monitoring or recording of the outcomes until the data collection was completed.

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)

盲法说明

study medications consists of identical shape pills of each study medication randomization is made by sealed envelops and a randomly sequence generated numbers.

patients and the research associate who collected the outcome data are blinded from the study group

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 years or older
  • acute (<24 hours) post traumatic pain of the extremity and requiring analgesic treatment upon discharge for pain with intensity >3 on a visual numeric scale
  • Exclusion criteria:
  • open fracture
  • head, abdominal, thoracic or polytrauma.
  • Need for hospitalization, regular use of paracetamol and NSAIDs during the two weeks before admission to ED
  • history of allergy or hypersensitivity to either paracetamol or NSAIDs,
  • contraindication to paracetamol or NSAIDs,
  • acute /history of GI hemorrhage and renal insufficiency,
  • an inability to assess pain intensity according to the VNS.
  • Pregnancy
  • heart failure
  • known hepatic cirrhosis
  • known severe renal impairment (Creatinine clearance <30 ml/min)
  • swallowing disorders
  • Refusal, incapacity or difficulties to consent or to communicate

排除标准

  • 未提供

研究组 & 干预措施

Parcetamol Group

Active Comparator

The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card.

干预措施: NSAID (Drug)

Parcetamol Group

Active Comparator

The patient receives an envelope containing Paracetamol 1000 mg at the dose of 3 times / day + follow-up sheet + appointment card.

干预措施: paracetamol-NSAID (Drug)

NSAID Group

Active Comparator

The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card.

干预措施: Paracetamol (Drug)

NSAID Group

Active Comparator

The patient receives an envelope containing NSAID 20 mg piroxicam twice daily / day + follow-up sheet + appointment card.

干预措施: paracetamol-NSAID (Drug)

NSAID + Paracetamol Group

Active Comparator

The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card.

干预措施: Paracetamol (Drug)

NSAID + Paracetamol Group

Active Comparator

The patient receives an envelope containing NSAID 20 mg piroxicam at a dose of 2 times/day + Paracetamol 1000 mg at a dose of 3 times / day + follow-up sheet + appointment card.

干预措施: NSAID (Drug)

结局指标

主要结局

new oral analgesic medications needed rate

时间窗: 3 days and 7 days

oral analgesic medications other than those of the protocol prescribed by the treating physicians or taken by patients' own volition

次要结局

  • the between-group difference in mean change in VNS score measured from ED discharge (VNS D0) to 7 days later(3 and 7 days)
  • The appearance of side effects(7 days)
  • the rate of ED readmissions for residual pain(3 and 7 days)
  • patient satisfaction assessed by Likert's verbal scale.(3 and 7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

Professor

University of Monastir

研究点 (1)

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