Assessing Impact of Preoperative Analgesics on Interoperative AndPostoperative Pain in Pediatric Patients Undergoing Primary Molar Pulpectomy : A RandomisedClinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in postoperative pain following primary molar pulpectomy in children.
研究概览
简要总结
This randomized clinical trial aims to evaluate the effectiveness of preoperative analgesics in reducing pain during and after pulpectomy procedures in children aged 4 to 9 years. The study will compare three groups: one receiving ibugesic , another receiving paracetamol , and a third receiving a placebo (Vitamin B-complex). The primary objective is to determine whether administering analgesics before treatment can improve pain control at various stages of the procedure. Pain levels will be assessed at five key time points: during local anesthesia injection, during the procedure, and at 1 hour, 4 hours, and 6 hours following the treatment. The results of this study may contribute to improved pain management strategies in pediatric dental practice, enhancing the comfort and overall experience for young patients undergoing pulpectomy.
Study Hypothesis: Children who receive ibugesic or paracetamol before a pulpectomy will report lower levels of postoperative pain compared to those who receive a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 4 to 9 years.
- •2.Children who need pulpectomy in mandibular primary molar 3.Children who are healthy (ASA I or II).
- •4.Children who can understand and follow simple instructions.
- •5.Children having Frankl Behaviour rating scale of 3 or
- •6.Children whose parents or guardians give written consent to take part in the study.
排除标准
- •1.Children who have allergies to any pain medication (like ibuprofen or paracetamol).
- •2.Children who are already taking painkillers or antibiotics before the treatment.
- •3.Children with acute infections, facial swelling, or abscess near the tooth.
- •4.Children with serious medical problems (e.g., heart conditions, kidney or liver disease).
- •5.Children with special healthcare needs or behavioral issues that may affect treatment.
- •6.Children who have received pulpectomy treatment in the same tooth earlier.
结局指标
主要结局
Reduction in postoperative pain following primary molar pulpectomy in children.
时间窗: 1.During local anaesthesia injection. | 2.During the procedure | 3.1 hour post procedure | 4.4 hours post procedure | 5.6 hours post procedure
次要结局
未报告次要终点