Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 3
- 主要终点
- Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
研究概览
简要总结
Pain is the leading cause of access to the paediatric emergency department (ED) and present in up to 78% of cases.
Acute osteoarticular traumatic pain is often treated inadequately, and there is little data about the best treatment for children. The ibuprofen and ketorolac are respectively the most used and one of the most powerful NSAIDs. In literature, there is no direct comparison between those two medications.
The objective of the study depends on the level of pain:
- in severe traumatic acute pain (>=7 points): to evaluate if ketorolac is superior to ibuprofen in the treatment of pain (n=130 children, 65 allocated to ketorolac and 65 to ibuprofen)
- in moderate traumatic acute pain (<7 points): to evaluate if ibuprofen is not inferior to ketorolac in the treatment of pain (n=120 children, 60 allocated to ketorolac and 60 to ibuprofen)
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double dummy
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 18 years
- •Moderate to severe pain (value>= 4 on the Numerical Rating scale / NRS)
- •Pain due to a trauma at limbs that has occurred in the last 48 hours
排除标准
- •Administration of any analgesic in the previous 8 hours.
- •Allergy known to one of the active ingredients
- •Known hepatopathy or nephropathy
- •Suspicion of violence by others
- •Chronic use of painkillers
- •Inability to report pain due to the presence of: intellectual disability (IQ <70); moderate-severe hearing loss; communication limitations such as patient mutism; unable to write; inability to speak Italian
- •Chronic neurological or metabolic diseases,
- •Positive history for ease of bleeding, coagulation disorder or
- •thrombocytopenia
- •A history of gastritis or esophagitis in the last 30 days
- •Multiple trauma
- •Vascular-vascular deficit
- •State of pregnancy
研究组 & 干预措施
Ketorolac
Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.
干预措施: Ketorolac (Drug)
Ibuprofen
Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug
时间窗: 60 minutes after the administration of the drug
NRS scale will be asked after 60 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment. The difference will be calculated from the baseline.
次要结局
- Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug(120 minutes after the administration of the drug.)
- Adverse effects in the two groups(within 120 minutes from the administration of the drug)
- Emergency department outcome(within 120 minutes from the administration of the drug)
- NRS 30 minutes after the administration of the drug(30 minutes after the administration of the drug)
- Patients who obtain a value of NRS <4 after 30 minutes from the administration of the drug.(30 minutes after the administration of the drug)
- Patients who obtain a value of NRS <4 after 60 minutes from the administration of the drug(60 minutes after the administration of the drug.)
- Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug.(90 minutes after the administration of the drug)
- Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug.(120 minutes after the administration of the drug.)
- Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug.(NRS scale will be asked after 30 minutes from the administration of the drug.)
- Patients who obtain a reduction of NRS of more than 3 points after 60 minutes from the administration of the drug.(60 minutes after the administration of the drug.)
- Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug.(90 minutes after the administration of the drug.)
- NRS at time 90 minutes after the administration of the drug(90 minutes after the administration of the drug)
- NRS at time 120 minutes after the administration of the drug(120 minutes after the administration of the drug)