Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Pain during nasogastric tube insertion
研究概览
简要总结
Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.
The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.
详细描述
In the context of mild to moderate dehydration in young children, enteral rehydration is the treatment of choice because it is more physiological than parenteral rehydration which has more serious side effects. Thus, nasogastric tube placement has become a more common procedure in the pediatric emergency care setting. Although, it is widely accepted that this procedure is invasive and painful, to date, no analgesic approach has been shown to be effective for children aged 3 months to 3 years. Currently, standard care is the placement of nasogastric tube without any analgesic intervention.
Inhalation of nitrous oxide mixed with oxygen (50/50) has been shown to be effective to reduce pain and anxiety induced by invasive procedures in children, adolescents and adults. Its use is very safe and it is associated with only minor and transient side effects such as nausea, vomiting or dizziness in les than 10% of patients. Its use is very common in many countries such as France, United Kingdom, The Netherlands or Australia. The investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.
The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.
A randomized controlled trial will be performed in two pediatric emergency departments to assess the efficacy of 50/50 nitrous oxide/oxygen during nasogastric tube insertion. The control group will receive standard care.
Primary outcome: Pain assessed with the FLACC scale during tube insertion
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 (Outcomes Assessor)
盲法说明
The primary outcome will be assessed on video recordings of the procedures which will be prepared so that assessors will not know to which group the children assigned. This correspond to a blind assessment of the primary outcome.
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child from 3 months to 3 years old.
- •Admission to the Pediatric Emergency Department
- •Medical prescription for the insertion of a nasogastric tube.
- •Child with gastroenteritis and / or bronchiolitis and / or food intolerance with mild to moderate dehydration
- •Parental presence and parental consent
排除标准
- •Vital emergency.
- •Refusal of parents to be filmed or to have their child filmed.
- •Child already included in the study or in course of participation in another study.
- •Tube placement performed by a medical student or nursing student.
- •Patient requiring 100% oxygen ventilation.
- •No social security.
- •Child with a mental handicap or known retardation.
- •History of child intolerance to Nitrous oxide ( excessive sedation or respiratory depression during previous use).
- •Child with head trauma in the previous 3 days.
- •Child with new-onset neurological abnormalities or other altered states of consciousness.
- •Child with intracranial hypertension.
- •Child with pneumothorax
- •Child having received in the last 3 months prior to inclusion an ophthalmic gas ( SF6, C3F8, C2F6)
- •Child with known vitamin B12 deficiency or unsubstituted folic acid.
- •Child who has had a diving accident.
- •Child with abdominal gas distension abdominal
- •Child with gas embolism
- •Child with pulmonary emphysema
- •Premature discontinuation of study participation :
- •Parents' request to stop participating in the study.
- •Insertion of the nasogastric tube is not possible
研究组 & 干预措施
Nitrous oxide
Inhalation of a 50%/50% mixture of nitrous oxide and oxygen. Reassurance of the child during procedure
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Pain during nasogastric tube insertion
时间窗: From the beginning of the procedures until 2 minutes after final positioning of the tube
Pain will be assessed during nasogastric tube insertion with the Face Legs Activity Cry Consolability (FLACC) scale composed of five scale (face, legs, activities, shouting, consolability). Each ranks from 0 to 2 : 0 is no pain, 1 is average pain, 2 is a strong pain The outcome measure is the sum of these five subscales: from 0 (better outcome) to 10 (worse outcome).
次要结局
- The potential side effects of the mixture 50%/50% nitrous oxide/oxygen for a brief inhalation are : Euphoria, dreaming, hallucinations, sedation, headaches, nausea, and vomiting.(from the start of inhalation to nearly 5 to 10 minutes after the end of inhalation)
- Child's constraint needed during the procedure(During procedure)
- Parent's anxiety 10 scale.(During procedure)