IBUPAP - Combination of Oral Ibuprofen and Acetaminophen (APAP) is Superior to Either Analgesic Alone for Pediatric Emergency Department (ED) Patients With Acute Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Score at 60 Minutes
研究概览
简要总结
Current literature supports ibuprofen and APAP are the most commonly used analgesics in the pediatric ED for acute traumatic/non-traumatic pain. However, the analgesic benefits of combination ibuprofen and APAP in this specific setting does not exist, but instead only as it applies to pediatric patients with postoperative pain. Thus, we have designed a double-blind, randomized, controlled clinical trial to evaluate analgesic efficacy, safety and feasibility of combination therapy to potentially broaden its clinical application in the pediatric ED. The investigators' hypothesize that combination oral ibuprofen and APAP therapy is superior to either drug alone and is an excellent analgesic modality for controlling acute traumatic/non-traumatic pain in the pediatric ED.
详细描述
The investigators' hypothesize the combination of oral ibuprofen and acetaminophen (APAP) is superior to either analgesic alone plus placebo for pediatric emergency department patients with acute traumatic/non-traumatic pain
- Intent to Treat, prospective, randomized, double-blind trial.
- Primary outcome: Pain reduction via NRS/FACES pain scale at times 0 and 60 minutes from administration of medication(s).
Secondary outcomes: Antipyretic effects, level of analgesia achieved with each patient diagnosis(es), incidence and type of adverse effect(s), and patients' and parents' satisfaction with achieved level of analgesia. 3. Population : ages 3 - 17. Sample size 90 patients (30 per arm). Group 1: oral ibuprofen at 10mg/kg dose and placebo of equal volume; Group 2: oral APAP at 15 mg/kg dose and placebo of equal volume; and, Group 3: oral ibuprofen at 10 mg/kg dose and APAP at 15mg/kg dose. 4. Location: Urban tertiary care hospital Pediatric ED with 40,000 annual departmental visits. 5. Duration of Enrollment: 1 year from commencement of the study.
6/7. Patients will be enrolled and randomized upon triage by an assigned nurse dedicated to the study into one of three groups by using a blocks-randomization scheme for every 15 patients maintained by the ED pharmacists.
- For patients experiencing breakthrough pain, oral morphine sulfate at 0.2mg/kg will be provided.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 3-17 years old presenting to the pediatric ED
- •treating physician deems patient required ibuprofen Tylenol or both for pain relief
排除标准
- •documented or suspected pregnancy, (2)
- •parental refusal,
- •allergies to NSAIDS or APAP
- •inability to tolerate oral medications or contraindications to oral medication route
- •received analgesics within 4 hours prior to ED presentation
- •inability to use pain scales
研究组 & 干预措施
Oral Ibuprofen and Oral APAP
Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.
干预措施: Ibuprofen (Drug)
Oral Ibuprofen
Oral Ibuprofen at 10mg/kg dose and placebo of equal volume
干预措施: Ibuprofen (Drug)
Oral APAP
Oral APAP at 15 mg/kg and placebo of equal volume
干预措施: APAP (Drug)
Oral Ibuprofen and Oral APAP
Oral Ibuprofen at 10mg/kg dose and APAP at 15mg/kg dose.
干预措施: APAP (Drug)
结局指标
主要结局
Pain Score at 60 Minutes
时间窗: 60 minutes
Pain Score via Numeric Rating Scale or FACES pain scale at 60 minutes from baseline ( ranging from 0 to 10, with 0 being no pain, 5 being moderate pain, and 10 being very severe pain)
次要结局
未报告次要终点
研究者
Antonios Likourezos
Co-Investigator
Maimonides Medical Center