The Influence Of Effective Post-Operative Pain Management Following Dental Treatment Under General Anesthesia On Parental Satisfaction And Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Efficacy of pain control using different medications
研究概览
简要总结
The main goal of this study is to test the efficacy of postoperative pain management for cases undergoing extractions of primary teeth under GA using a validated measure.
Children undergoing extraction of at least one primary molar under general anesthesia GA at King Abdullah University Hospital (KAUH) were randomly assigned into three groups: study group (1) were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days, study group (2) were given Ibuprofen three times daily for 3 days, study group (3) were given Paracetamol prn for 3 days.
pain was assessed using parent's postoperative pain measure (PPPM) on the first, second and third days.
详细描述
After ensuring the fulfillment of inclusion criteria, data were collected on three phases as follows:
Pre-Operative By interviewing the parents preoperatively during the waiting time, consent was obtained via a consent form , sociodemographic data (name, age, and date of the operation) were also collected using parental questionnaire .
Preoperative pain was measured using WBFPRS. Pre- and postoperative pain scales were explained to parents by the research assistant.
Intra-Operative Data were collected on anesthesia protocol , and dental treatment performed.
Anesthesia Protocol Data about anesthesia protocol were collected to ensure fulfilment of inclusion criteria, this includes mode of induction (IV or inhalational), tube type (nasal or oral), tube size, intra-operative medications (Dexamethasone and analgesia) doses and repetition , cases which did not fulfil the anesthesia protocol were excluded.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
blinding of investigators and outcome assessor was possible however no blinding of the participant
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fit and healthy patients, ASA I without cognitive or mental disabilities.
- •Aged between 4-8 years.
- •No preoperative moderate to severe pain.
- •Not receiving pain medication prior to GA.
- •Not allergic to any of the prescribed medications.
- •Undergoing at least one posterior tooth extraction.
- •Parent signed the consent form.
排除标准
- •Children requiring extraction of permanent molars to ensure standardization.
- •Patients who had no extractions at all.
- •Cases of difficult intubation as pain of difficult intubation could be confused with dental pain
- •Cases where it was necessary to repeat intra-operative analgesic medication (Fentanyl).
- •Diclofenac sodium suppository was not given at the end of the procedure.
- •Anesthetist did not follow the standardized anesthesia protocol existing in KAUH like cases where a sedative medication like Ketamine was given preoperatively.
研究组 & 干预措施
Study group 1 (bimodal)
participants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days,
干预措施: Ibuprofen 200 mg (Drug)
Study group 1 (bimodal)
participants were given Ibuprofen and Paracetamol alternately every 8 hours for 3 days,
干预措施: paracetamol (Drug)
study group 2
Participants were given Ibuprofen three times daily for 3 days
干预措施: Ibuprofen 200 mg (Drug)
Control group
Paracetamol PRN based on parental assessment of pain
干预措施: paracetamol (Drug)
结局指标
主要结局
Efficacy of pain control using different medications
时间窗: 3 days post operative
Reduction in pain scores using the parental post operative pain measure, by comparing scores immediately post operative with scores on subsequent days. higher scores indicate worse pain
次要结局
- Quality of life of treated children(2 weeks post operative)