跳至主要内容
临床试验/NCT01911351
NCT01911351已完成不适用

High Concentration Continuous Flow Nitrous Oxide Use for Procedural-induced Pain or Anxiety During Pediatric Minor Procedures

New York City Health and Hospitals Corporation1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
FLACC Pain Scale

研究概览

简要总结

Title:

High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety during pediatric minor procedures.

Objective: To assess whether the use of high-concentration continuous flow nitrous oxide in addition to standard management increases the comfort level in pediatric patients undergoing minor procedures compared to standard management alone.

详细描述

Title:

High-concentration continuous flow nitrous oxide use for procedural-induced pain or anxiety during pediatric minor procedures

Brief Summary:

Background: Over the past 10 years pediatric emergency departments (PED) throughout the country have adopted the concept of an "ouchless" PED, using both pharmacologic and non-pharmacologic methods to achieve this goal. There are a number of minor procedures performed routinely in a PED. Despite our interest in an "ouchless" PED, many of these procedures are performed without full attention to patient comfort. Some procedures, such as laceration repair, require local anesthesia, while others, such as intravenous catheter placement, are usually performed without local anesthesia. All of these minor procedures, however, are ones in which the risk of parenteral procedural sedation outweighs the benefit.

Due to the awareness of trying to create as pain-free an experience as possible, the use of high-concentration nitrous oxide (>50%) in the pediatric outpatient setting has grown and is used in PEDs throughout the country. Nitrous oxide is a colorless, non-narcotic, analgesic gas. Its efficacy and safety have been well documented in anesthesia, pediatric and dental literature. Over the last 30 years, nitrous oxide has been incorporated in the outpatient pediatric setting for procedural analgesia. At Jacobi Medical Center (JMC), nitrous oxide has been successfully used for children undergoing a variety of minor procedures in the PED.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Minor Procedure
  • •Age 3 - 12 years

排除标准

  • •Behavioral Disorders
  • •Anxiety Score <10

研究组 & 干预措施

Nitrous Oxide

Experimental

Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.

干预措施: Nitrous Oxide (Drug)

结局指标

主要结局

FLACC Pain Scale

时间窗: peak pain during procedure approximately 2-5 minutes into the procedure

The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.

次要结局

  • M-YPAS Anxiety Scale(measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验