The Effect of Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- categorical score
研究概览
简要总结
The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized clinical trial
详细描述
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Diagnosis:
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Diagnostic chart will be filled with personal, medical and dental history. DMF and def.
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Clinical examination (intra oral and extra oral) will be done by mirror and probe to assess the inclusion criteria. All materials will be packaged in sterilizations wraps and autoclave following the required bio safety standards.
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Intervention:
Experimental Groups:
Group 1: Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott). Group 2: Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
statistician will be blind only
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7-12 years who need extractions under local anesthesia.
- •Those having a parent/guardian to understand and comply with the requirements of the protocol and able to fill an appropriate written informed consent.
- •Children and parents who agree to wait for the stipulated time before and after the extraction.
排除标准
- •Children with acute pain.
- •Patients taking analgesics within 5 hours prior to the dental extraction.
- •Patients with a history of prolonged bleeding, platelet disorders, hypersensitivity, or allergic reactions to analgesics or any of the drugs tested.
- •Patients without a home telephone or without parental supervision for the post- operative period.
研究组 & 干预措施
intervention arm
Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott) will be given 30 min before injection of local anesthesia. Then pain scores will be recorded from 0-4.
干预措施: Ibuprofen (Drug)
intervention
Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline) will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4.
干预措施: paracetamol (Drug)
comparator
A fruit-flavored orange color placebo solution will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4.
干预措施: A fruit-flavored orange color placebo solution (Dietary Supplement)
结局指标
主要结局
categorical score
时间窗: 1 hour
mild, moderate, sever, very sever
次要结局
- binary(1 day)
研究者
Rehab Abdelrahman Elshenawy
Principle investigator
Cairo University