Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Post-operative pain evaluation
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of pre-emptive analgesia using ibuprofen and paracetamol on reducing post-operative pain following the placement of stainless steel crowns on primary molars compared to placebo
详细描述
The study will be a parallel, placebo-controlled, triple-blinded, randomized clinical trial. A total of 66 healthy children aged 5-8 years requiring the placement of a stainless steel crown will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The children will be randomly allocated into three groups according to the type of pre-emptive solution used. Group I will receive ibuprofen, group II will receive paracetamol, while group III (control) will receive a placebo solution. Children will self-report their level of pain using a Visual analogue scale (VAS) and/or a Facial pain scale (FPS) after local anesthesia administration, immediately after the cementation of the stainless steel crown, and 2, 6 and 24 hours post-operatively. Children's baseline anxiety and parental anxiety will also be assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant inclusion criteria:
- •Age range 5 to 8 years old
- •Children without any previous interventional dental experience
- •Children free of any systemic disease or special health care needs (ASA 1)
- •Children free of any allergies or hypersensitivity reactions to local anesthetics or analgesic drugs
- •Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
- •Parents/caregivers and children who are willing to participate in the study
- •Tooth inclusion criteria:
- •Maxillary first or second primary molar teeth with extensive and/or multisurface caries where other restorations are likely to fail but without pulp exposure
- •Absence of clinical and radiographic signs or symptoms of irreversible pulpitis
- •Absence of fistula or abscess near the selected tooth clinically and radiographically
- •Absence of spontaneous pain
- •Absence of pulp exposure
- •Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually
排除标准
- 未提供
研究组 & 干预措施
Group I (Ibuprofen)
Participants will receive ibuprofen 100 mg/5 ml (BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.) The solution will be administered Once, 1 hour prior to the local anesthesia administration.
The participant will receive a weight-dosed volume Effective dosages range from 10 mg/kg/day to a maximum of 40 mg/kg/day
干预措施: Ibuprofen (Drug)
Group II (Paracetamol)
Participants will receive paracetamol 250 mg/5 ml (CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.) The solution will be administered once, 1 hour prior to the local anesthesia administration.
The participant will receive a weight-dosed volume Effective dosages are between 15-20mg/kg/day to a maximum of 60 mg/kg/day
干预措施: Paracetamol (Drug)
Group III (Placebo)
The placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
干预措施: Placebo (Other)
结局指标
主要结局
Post-operative pain evaluation
时间窗: Day1 (24 hours post-operatively)
Pain will be measured via a visual analogue scale (VAS) based on a straight line of 100 mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a facial pain scale.Children will self-report their level of pain four times post-operatively
次要结局
- Trans-operative pain evaluation(Day 0 (During Procedure))
- Evaluation of parental anxiety(Day 0 (In the waiting room before the intervention))
- Evaluation of the child's dental anxiety(Day0 (In the waiting room before the intervention))
研究者
Farah Nemr
Instructor
Alexandria University