30 % Nitrous oxide - Oxygen (N2O/O2) Inhalation sedation -standard titration vs rapid titration - a randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effect of 30% nitrous oxide -oxygen (N2O / O2) inhalational sedation: standard
研究概览
简要总结
q Nitrous oxide/oxygen inhalation, also referred to as N2O/O2 analgesia/anxiolysis, is a safe and effective technique used to manage dental pain and anxiety.
q It may prove as invaluable pharmacological behavior management technique during challenging procedures like local anesthesia in pediatric patients.
q Technique of nitrous oxide administration can be divided into two types :1. slow titration or the standard titration 2. Rapid titration
q As there are not many studies reported regarding the rapid titration method the present study is planned to compare the effectiveness of two types of titration techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children indicated for procedure requiring administration of local anesthesia.
- •Children falling under the ASA group I & II.
排除标准
- •Children falling under the ASA group III & IV and V.
- •Chronic obstructive pulmonary diseases.
- •Current upper respiratory tract infections (e.g., cold, cough, tonsillitis), sinusitis, or other conditions (e.g., seasonal allergies) that inhibit nasal breathing.
- •Recent middle ear disturbance or infection (e.g., acute otitis media).
- •Recent (within 14 days) ear, nose, and/or throat operations.
- •Raised intraocular pressure (e.g., glaucoma), up to three months post retinal surgery.
- •Severe emotional disturbances or drug-related dependencies.
- •Treatment with bleomycin sulfate.
- •History of cobalamin (vitamin B12) deficiency.
结局指标
主要结局
To evaluate and compare the effect of 30% nitrous oxide -oxygen (N2O / O2) inhalational sedation: standard
时间窗: assessment of measuring scales before and after 10 minutes of giving local anesthesia for dental treatment
vs rapid titration on physiologic and analgesic parameters in pediatric patient while giving local anesthesia
时间窗: assessment of measuring scales before and after 10 minutes of giving local anesthesia for dental treatment
次要结局
- To evaluate & compare the patient & parent acceptance between two titration techniques(assessment of measuring scales before & after 10 minutes of giving local anesthesia for dental treatment)
研究者
Mahima Shokhanda
SGT University