Inhaled Methoxyflurane for Pain Management in Nasal Bone Fracture Reduction : A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain level variation during nasal closed reduction: visual analog scale
研究概览
简要总结
This is a randomised, double-blind, placebo controlled study to evaluate the efficacy of Methoxyflurane (Penthrox®) for the treatment of acute pain during closed nasal fracture reduction.
The study aims to provide evidence under blinded controlled conditions that Penthrox is safe and effective in patients aged 18 to 65 years during closed nasal fracture reduction.
详细描述
The main objective of this study is to establish if the addition of Methoxyflurane to local anesthesia has the ability to significantly reduce the pain during closed nasal fracture reduction compared to local anesthesia with placebo.
The secondary outcomes consist of assessing if inclusion of Methoxyflurane will have a positive impact on the time needed to achieve the reduction, the need for backup analgesia, the rate of reduction failure, pain level during infiltration of local anesthesia and the clinician's appreciation of the procedure.
As an hypothesis, the investigators expect that the addition of Methoxyflurane to the standard local anesthesia will significantly reduce the pain compared to local anesthesia with placebo during closed nasal fracture reduction. The investigators also think that Methoxyflurane might reduce the duration of the reduction, limit the need for backup analgesia, reduce the rate of reduction failure, reduce the pain level due to infiltration of local anesthesia and facilitate the procedure for the clinician.
To reach these objectives, the investigators propose a randomized, double-blind, placebo-controlled study on a sample of patients randomized in two different groups:
- Group A (intervention) : Closed nasal fracture reduction under local anesthesia and inhaled Methoxyflurane.
- Group B (control) : Closed nasal fracture reduction under local anesthesia and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The placebo in this study is a 0,9% saline solution that comes in an identical inhaler as the Methoxyflurane. The inhaler for both group will be prepared by the research pharmacist right before the procedure. The characteristic smell of the Methoxyflurane solution will be reproduced by pouring a few drops of Methoxyflurane just above the tip of the inhaler a couple of minutes before the administration of the Methoxyflurane or placebo (will be done for both groups by a pharmacy technician experienced in double-blind research - CIUSSS de l'Estrie-CHUS site Hôtel-Dieu) to make sure that the double-blind design is respected. The pharmacy is located inside the hospital near the outpatient clinic so packages will be easily available within minutes when patients are recruited. In addition, to lower the risk of group identification, a N-95 mask will be worn during each procedure by the investigators and the research nurse.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a man or a woman between 18 and 75 years old, inclusively ; and
- •Being covered by the Quebec medical insurance (RAMQ); and
- •Presenting an uncomplicated nasal fracture requiring a delayed (7 to 10 days) closed reduction.
排除标准
- •Pregnant or breastfeeding woman; or
- •Known for renal insufficiency (DFG < 50) ; or
- •Known for hepatic impairment; or
- •Personal or familial allergies/hypersensitivity to fluorinated products; or
- •Contraindications to local anesthesia (including allergies); or
- •Personal or family history of malignant hyperthermia; or
- •Other facial fractures and/or significant injuries; or
- •Altered state of consciousness (dementia, drug intoxication, head trauma or other similar psychologic disorder); or
- •Significant respiratory impairment; or
- •Haemodynamic instability; or
- •Simultaneous use of alcohol, isoniazid, phenobarbital, rifampin, opioids, sedatives, hypnotics, sedative antihistaminics, general anesthetics, phenothiazines, tranquilizers, myorelaxants, nephrotoxic antibiotics (tetracycline, gentamicin, colistine, polymyxin B, amphotericin B); or
- •Use of cannabis or other illicit drugs the day of the procedure; or
- •Use of pain medication in past 6 hours; or
- •Use of Methoxyflurane : more than 6 mL in the last 48 hours or more than 15 mL in the last week or usage in the last 3 months; or
- •Need of sedation or general anesthesia for the procedure.
结局指标
主要结局
Pain level variation during nasal closed reduction: visual analog scale
时间窗: The "baseline pain" will be assessed before local anesthesia will be administered (at the very beginning of the procedure), whereas the "mean pain" and the "peak pain" will be assessed after the closed reduction is completed.
The primary outcome is pain level variation during the closed reduction. Three pain levels will be collected using the visual analog scale : * Pain level before the procedure (or "baseline pain") : will be assessed in order to analyse pain variation during the procedure between the two groups * Mean pain level during the procedure (or "mean pain"), defined as the average amount of pain felt throughout the procedure by the patient * Peak pain level during the procedure (or "peak pain"), defined as the worst pain that the patient had felt during the procedure The visual analog scale is a validated scale on which patients are asked to report their pain level, from zero (absence of pain) to 10 (worst pain imaginable). Pain variation during the procedure will be assessed using two outcome measures : 1. The mean pain due to procedure (the difference between the "mean pain" and the "baseline pain") 2. The peak pain during the procedure, as measured on the visual analog scale
次要结局
- Time needed to achieve the reduction(The time needed to achieve the reduction will be calculated by subtracting the time at the beginning of the reduction to the time at the end of the reduction, which will be documented by a research nurse during the procedure.)
- Rate of participants requesting backup analgesia during the procedure(Immediately after the intervention)
- Reduction failure rate(Immediately after the intervention)
- Pain level during anesthesia: visual analog scale(Immediately after the intervention)
- Number of procedures limited by pain(Immediately after the intervention)
研究者
Pierre-Hugues Fortier
M.D., Clinical professor, Otolaryngology and Head & Neck Surgery
Université de Sherbrooke