Clinical Evaluation of Penthrox (Methoxyflurane)and Tramadol for the Singapore Emergency Ambulance Service
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Change in Pain Score assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
Introduction
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF) EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug.
Aim
To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by the SCDF EAS.
Methodology
The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per station level. After 6 months, they will cross over to Penthrox and tramadol respectively.
All paramedics will be trained to use both medications, pain scales and Ramsey scores, and will record patient's pain, sedation scores and patient satisfaction as part of routine clinical practice. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects.
Hypothesis
The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS) at 5, 10, 15 and 20 min after start of the study treatments.
详细描述
Introduction
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. In addition, there are problems with storage, leakage, maintenance and occupational exposure of the EAS crew members. Therefore, there is a need for better standard of care treatment.
Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug. We intend to conduct a clinical evaluation trial comparing the use of inhaled Penthrox with IM Tramadol for early pain relief.
Objective & Hypothesis
Primary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute pain, with pain score greater than 3, presenting with musculo-skeletal trauma (limbs or back) pain are eligible
- •Conscious, haemodynamically stable condition (BP greater than 90/60)
- •Age more than 16 years old
排除标准
- •Females who are nursing or with a positive pregnancy test (pregnant)
- •Patients with major head injury or impaired consciousness
- •Acute intoxication with drugs or alcohol, or other conditions that might impair ability to score pain
- •Chronic pain requiring ongoing use of analgesics
- •Abdominal or chest pain (for the purpose of this initial implementation study)
- •Penthrox only
- •Known pre-existing renal or hepatic impairment
- •Hypersensitivity to fluorinated anaesthetics or a history of possible adverse reactions in either the patients or relatives (malignant hyperthermia)
- •Concomitant use of nephrotoxic medications such as gentamicin or tetracycline
- •Tramadol only
- •Any allergies to tramadol or codeine
- •Any history of seizures, epilepsy
- •Patients who are taking anti-depressants
研究组 & 干预措施
Tramadol
Tramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time
干预措施: Tramadol Injection (Drug)
Penthrox
Dosage form: Inhalation; Strength: 3ml/bottle; Frequency: Up to 6ml per day. Total weekly dose should not exceed 15ml.
干预措施: Penthrox Inhaler (Drug)
结局指标
主要结局
Change in Pain Score assessed by Visual Analogue Scale (VAS)
时间窗: 5, 10, 15 and 20 min
次要结局
- Change in Ramsay sedation Scores(5, 10, 15 and 20 min)