A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration
研究概览
简要总结
The objective of this project is to compare the sedative effects of intranasal midazolam versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency department. The primary outcome will be length of stay (LOS) in the emergency department (ED) stay for minor procedures. Secondarily the investigators will compare patient/family and provider satisfaction while using either intranasal midazolam or N2O for minimal sedation. The investigators hypothesize that the total length of stay for children undergoing minor procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The investigators also hypothesize that patient/family and provider satisfaction will be higher with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients will receive either intranasal midazolam or N2O for minor procedures. Following the enrollment period, data will be analyzed and the two will be compared. Total length of stay, patient/family and provider satisfaction will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥2 years of age and <18 years of age, and
- •Parent/legal guardian age ≥18 years of age to <80 years of age
- •Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System level 1, 2, and 3
- •Patients requiring anxiolysis and mild sedation for minor procedures
- •Minor procedures will include simple lacerations less than 4 cm
- •Lumbar punctures
- •Minor incision
- •Drainage of abscesses that do not require extensive debridement
- •Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam.
- •Nitrous oxide up to 70% nitrous concentration will be allowed
- •Intranasal Midazolam 0.4mg/kg with a max dose of 10mg
排除标准
- •Nasal injury, nasal obstruction or significant congestion
- •Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing
- •Allergy to benzodiazepines
- •Benzodiazepine dosing for any reason 24 hours prior to procedure
- •Excessive Epistaxis
- •Facial or nasal deformity
- •Copious mucous
- •Recent (less than 1 week) tympanic membrane graft or middle ear surgery
- •Recent bleomycin therapy
- •Patients known to be pregnant at time of enrollment
- •Patients with severe behavior problems, personality disorders or other mind-altering conditions as determined by administering provider.
- •Closed space situations such as:
- •pneumothorax,
- •air embolus,
- •pneumocephalus, or
- •craniotomy in the last 3 weeks,
- •intraocular surgery with retained gas,
- •pulmonary bullae,
- •severe emphysema, or
- •bowel obstruction.
- •Patients with significant co-morbidities:
- •severe pulmonary disease,
- •cardiac disease,
- •hematologic diseases associated with B12 deficiency,
- •sickle cell disease.
- •Patients with acute otitis media and/or sinusitis
- •History of paradoxical reaction to nitrous oxide
- •Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients
- •Co-administration of additional sedation or analgesic medications
研究组 & 干预措施
Nitrous Oxide
Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.
干预措施: Nitrous Oxide (Drug)
Intranasal Midazolam
Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.
干预措施: Midazolam (Drug)
结局指标
主要结局
ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration
时间窗: From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours.
The total length of Emergency Department (ED) stay will be defined as time from intranasal midazolam or nitrous oxide administration to time of discharge readiness, collected by the research assistants. Additional time periods measured will include: time from anxiolytic/sedative given to time of procedure completion, and total time for recovery.
次要结局
- Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative.(Time of discharge, Approximately 2 hours)
- Adverse Events.(Time of discharge, Approximately 2 hours)