Analgesic Efficacy of Intra-muscular Ketamine-ketorolac Versus Fentanyl- Ketorolac for Children Undergoing Bone Marrow Biopsy and Aspiration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy
详细描述
regarding patient registry; a prior G power analysis was done. Based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences), program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status II
排除标准
- •Any known allergy to the studied drugs.
- •congenital heart disease
- •Any cardiac problems.
- •Use of psychotropic medication
- •mental retardation
- •any organ dysfunction
研究组 & 干预措施
ketamine-ketorolac
The patient will receive ketamine in conjunction with intramuscular ketorolac
干预措施: ketamine-ketorolac (Drug)
fentanyl- ketorolac
The patient will receive fentanyl in conjunction with intramuscular ketorolac
干预措施: fentanyl- ketorolac (Drug)
结局指标
主要结局
Postoperative pain
时间窗: for 60 minutes later admission to the post-anaesthesia care unit
Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale)The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain). When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
次要结局
- Heart rate(at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes)
- total number of children who required postoperative pain medication(for 24 hours after surgery)
- nausea, vomiting(during first 24 hours postoperative)
- systolic blood pressure(at the baseline (after the induction of anesthesia and before administration of the drugs) then every 5min up to 20 minutes)
- The time to the first demand for rescue analgesic(during first 24 hours postoperative)
- emergence behavior(every 5 minutes during first 30 minutes of recovery)
- respiratory difficulty(during first 24 hours postoperative)