Comparative evaluation of buffered 4% articaine versus 4% articaine in pain perception following labial infiltration in children.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the pain perception in pediatric patients following labial infiltration using buffered 4% articaine versus conventional (non-buffered) 4% articaine, as assessed by validated pain scales during labial infiltration.
研究概览
简要总结
The study will include sixty children aged 4 to 8 who require extraction of primary maxillary incisors and who fulfill the criteria.
The demographic details, brief case history, and clinical findings of each patient will be recorded.
Following clinical examination, the Wong-Baker Faces Pain Rating Scale1 and Sound Eye Motor Scale1 will be explained to the patient. The children will be divided into 2 groups:
Group 1: Thirty children will be administered buffered 4% articaine with 1:100,000 epinephrine (will be prepared prior to administration)
Group 2: Thirty children will be administered 4% articaine with 1:100,000 epinephrine
Preparation of 4% buffered articaine solution: 0.18 ml of solution will be collected from 1.8ml cartridge of 4% articaine (1.8ml cartridge, Septanest®, marketed by Septodont Healthcare India Pvt. Ltd., Maharashtra, India) in a 1ml insulin syringe and then 0.18ml of 8.4% sodium bicarbonate (Sodac®, marketed by Uttaranchal Biotech Limited, Rudrapur, Uttarakhand, India) will be added into the cartridge just before administration.
The children will be allocated to either of the groups using simple randomization. Following topical application of 8% lidocaine and 0.8% Dibucaine gel (Precaine, Pascal International, Inc, USA) for 1 minute at the site of injection, labial infiltration using a sterile disposable insulin syringe and 31gauge needle will be used to inject either 1ml of 4% articaine or 1ml of 4% buffered articaine.
In both groups, the local anesthetic solution will be administered over a period of 60 seconds. The onset of anesthesia will be recorded every 30 seconds using a blunt probe on the labial and palatal aspects of the gingiva. It will be recorded in minutes as the interval between the time of administration to the time when the effect of anesthesia will be first reported. After achieving adequate anesthesia, the primary maxillary incisors will be extracted. The efficacy of anesthesia will be assessed by subjective and objective signs. Intraoperative pain will be recorded using the Wong-Baker Faces Pain Rating Scale1, where 0 indicates no pain and 10 indicates intense pain. The objective signs will be recorded using the Sound Eye Motor scale1, where 1 indicates comfort and 4 indicates painful.
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 and Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate in the study.
- •Patients exhibiting Frankl’s behaviour rating 3 or
- •Patients requiring non-surgical extraction of primary maxillary incisors.
- •Primary maxillary incisors that cannot be restored.
排除标准
- •Patients with a known history of allergy to any of the constituents present in the local anesthetic agent.
- •History of medically compromised conditions.
- •Presence of acute dento-alveolar infection at the site of injection.
- •History of dental treatment in the past 6 months.
- •Presence of pathological lesion involving primary maxillary incisors.
- •Presence of pain in relation to primary maxillary incisors.
- •Patients who have taken analgesics in the last 24 hours.
结局指标
主要结局
To compare the pain perception in pediatric patients following labial infiltration using buffered 4% articaine versus conventional (non-buffered) 4% articaine, as assessed by validated pain scales during labial infiltration.
时间窗: baseline
次要结局
未报告次要终点
研究者
DR PANDIT SUSAANA AUSTINE
THE OXFORD DENTAL COLLEGE