Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 20
- 主要终点
- Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).
研究概览
简要总结
Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency Department to compare two ways of morphine titration. The eligible patient is included immediately after his arrival in the Emergency Department, after being questioned by the triage nurse about the presence and the intensity of pain, when the VAS is greater than 70 (or EN>7) and after written consent.
After installation into the examination room, patient is randomized in one of two parallel groups (stratified by sex and center using software) and receives one of the two treatments, either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).
In both groups, titration is defined by a dose of repeated boluses as long as the relief is not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.
A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.
Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of 6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief, are linked to the occurrence of side effects and specific cares are described into the protocol (in case of severe ventilatory depression naloxone titration is provided). Exit criteria from the emergency room and from the hospital are defined. An information sheet is delivered.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and <75 years old;
- •EVA ≥ 70/100 or EN ≥ 7/10;
- •Patient who received clear information from the investigator and read and signed the consent form;
- •Patient affiliated with, or beneficiary of a social security category;
- •For women:
- •O of childbearing age: effective contraception (oral contraception, intrauterine device or use of condoms) O menopausal status (amenorrhoea less than 12 months before the inclusion visit) O objectivized sterility (diagnosis or surgically)
排除标准
- •Chronic pain (> 3 months)
- •Taking opioids longer than 10 days (including "weak" opioids tramadol and / or codeine);
- •Taking Rifampicin;
- •Impaired ability to discern, cognitive impairment;
- •Morphine-related contraindications:
- •O Obstructive chronic obstructive or restrictive respiratory failure known or suspected compensated or not, O Hypersensitivity to the active substance or to any of the excipients, O Severe hepatocellular insufficiency (known or suspected), O Chronic renal failure known or suspected, O Uncontrolled epilepsy, O Cranial trauma (intracranial hypertension), O Associations with buprenorphine, nalbuphine, pentazocine and naltrexone
- •Active drug history or practice (s);
- •Evidence of reduced fracture or dislocation in emergency rooms;
- •Suspected occlusive syndrome
- •SaO2 <95%;
- •FR <12 / min;
- •Glasgow <15 or other alertness disorders;
- •HR heart rate <50 bpm and / or Auriculo-Ventricular block (PR XML File Identifier: zR6XOYKSEQ9GjQHghP8c465EwF0= Page 15/30 interval> 200 ms);
- •Arterial hypotension with systolic blood pressure TA syst <100 mm Hg;
- •Pregnant or nursing
- •Persons deprived of their liberty by an administrative or judicial decision, a person placed under the safeguard of justice, guardianship;
- •Patients with poor comprehension of spoken or written French;
- •Patients participating in another interventional clinical study;
- •Contra-indication related to the use of saline solution
- •Contra-indications related to the use of aerosol:
- •O Necessity to access the face O Allergy known to plastic
研究组 & 干预措施
inhaled morphine + IV placebo
Arm A: inhaled titration of morphine chlorhydrate+ IV placebo
干预措施: inhaled titration of morphine chlorhydrate (Drug)
inhaled morphine + IV placebo
Arm A: inhaled titration of morphine chlorhydrate+ IV placebo
干预措施: IV placebo (Drug)
IV morphine +inhaled placebo
Arm B:IV titration of morphine chlorhydrate + inhaled placebo
干预措施: Inhaled placebo (Device)
IV morphine +inhaled placebo
Arm B:IV titration of morphine chlorhydrate + inhaled placebo
干预措施: IV titration of morphine chlorhydrate (Drug)
结局指标
主要结局
Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).
时间窗: 1 hour after the initiation of the titration
Rate of relief obtained or "success rate" at 1 hour from the start of drug administration, and not at the end of titration, such as EVA1 ≤ 30/100 (or EN1 ≤ 3/10).
次要结局
- Assess the feasibility of an aerosol titration (compliance to the protocol)(From the beginning of the titration until the end of the aerosol titration- within one hour after the start of the titration)
- Safety-Proportion of Sleepy patients (Ramsay score = 3) (adverse events)(Until 3hours after the end of the titration)
- Evaluate antalgic efficacy criteria(2hours after the initiation of the titration)
- Safety- Proportion of serious adverse events in each arm(Until 3hours after the end of the titration)
- Safety- incidence of minor side effects in each arm of which neurovegetative usually known and related to opiates (nausea, vomiting, urine retention, ...)(Until 3hours after the end of the titration)
- Evaluate antalgic efficacy criteria(From the beginning of the titration until the end of the titration- assessed within one day)
- Evaluate antalgic efficacy criteria(From the beginning of the titration until the end of the titration- assessed up to one day)
- Evaluate antalgic efficacy criteria(30 minutes after the initiation of the titration)
- Evaluate antalgic efficacy criteria(1hour after the initiation of the titration)