Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Assessment pain related to the injection of the local anesthesia using WBFS.
研究概览
简要总结
Brief Summary:
Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen, Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary tooth extraction, and to compare the parents' satisfaction.
Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old.
详细描述
Background and Aims: The pain could be a problem for the patients during the first few hours after the extraction because of both soft and hard tissues trauma during the operation, despite that the local anesthesia will last for a long time in most of the cases.
There are no enough studies that ensure the validity of giving any analgesic in reducing injection pain and post-operative pain in primary tooth extraction so far.
Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated medication bottles, which are identical, numbered and containing the same amount of pre-calibrated dosages, as per the following portions:
- Acetaminophen syrup: 160mg/5ml
- Placebo solution
- Ibuprofen suspension: 100mg/5ml
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
- Double (Participant, Investigator)
盲法说明
The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Teeth with an abscess or infection exceeding one-third of the interradicular area (not exceeding the oral cavity)
- •Unrestorable decayed teeth.
- •Teeth with periapical / interradicular lesions.
排除标准
- •Teeth with advanced root resorption (a third of the root at least)
研究组 & 干预措施
A (Acetaminophen)
22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection.
干预措施: Acetaminophen (Drug)
B (Placebo)
22 children will receive 10ml 30 minutes before the local anesthesia injection.
干预措施: Placebo (Drug)
C (Ibuprofen)
22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Assessment pain related to the injection of the local anesthesia using WBFS.
时间窗: 30-60 seconds after injection of the local anesthesia.
The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.
Post operative pain assessment using WBFS.
时间窗: 10 minutes - 6 hours after the extraction.
After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale. Re-evaluate the pain after 15minutes from the extraction. The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.
次要结局
- Evaluate the parents' satisfaction using Likert fifth scale.(6 hours after extraction.)
研究者
Nabih Raslan
Principal Investigator
Tishreen University